Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Cancer

Purpose

This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin Hylecta [TM]) or pertuzumab, trastuzumab and hyaluronidase-zzxf (Phesgo [TM]) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial cancer. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial cancer.

Conditions

  • Endometrial Carcinoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Dedifferentiated Carcinoma
  • Endometrial Endometrioid Adenocarcinoma
  • Endometrial Mixed Cell Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Endometrial Undifferentiated Carcinoma
  • Uterine Corpus Carcinosarcoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA-IVB, non-recurrent, chemotherapy (chemo)-naive, HER2-positive endometrial cancer. The following endometrial cancer types are eligible: - Serous - Other endometrial cancers (including clear cell, endometrioid, mixed epithelial, dedifferentiated/undifferentiated) - Carcinosarcoma - NOTE: Endometrial cancers that are mismatch repair deficient (dMMR) by IHC are not eligible - Histologic confirmation of the original primary tumor is required. Submission of surgical pathology report (or endometrial biopsy pathology report in patients who never undergo hysterectomy) is required - Patients must be within 8 weeks of primary surgery (or endometrial biopsy in patients who never undergo hysterectomy) at the time of study registration - Patients may have measurable disease, non-measurable disease, or no measurable disease. In patients with measurable disease, lesions will be defined and monitored by RECIST v 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by CT or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI - For patients with uterine-confined (stage I) disease, the tumor must be invasive into the myometrium. Any amount of myoinvasion is acceptable for eligibility. Patients with non-invasive disease, endometrial intraepithelial carcinoma alone, or disease confined to a polyp will be excluded - All patients must have tumors that are HER2 positive as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 Breast Cancer guidelines (https://documents.cap.org/documents/algorithim-evaluation-her2.pdf.) IHC and ISH testing will be done locally, at each participating institution and interpreted by local pathologists. In general HER2 positivity is defined as any of the following: - 3+ immunohistochemistry (IHC), - 2+ IHC with positive in situ hybridization (ISH) Alternatively, patients could be eligible if next generation sequencing (NGS) demonstrates HER2 (ERBB2) amplification. NGS testing can be performed through any designated labs as per the National Cancer Institute (NCI) MATCH/NCI Combo-MATCH trial (https://ecog-acrin.org/nci-match-eay131-designated-labs). Pathology report showing results of institutional HER2 testing (or NGS testing results) must be submitted. Sites must submit all results available (IHC, ISH, and NGS) - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 - Age >= 18 - Platelets >= 100,000/mcl (within 14 days prior to registration) - Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to registration) - Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN) or estimated Glomerular filtration rate (eGFR) >= 50 mL/min using either the Cockcroft-Gault equation, the Modification of Diet in Renal Disease Study, or as reported in the comprehensive metabolic panel/basic metabolic panel (eGFR) (within 14 days prior to registration) - Total serum bilirubin level =< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =< 3 x ULN may be enrolled) (within 14 days prior to registration) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to registration) - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial - Although the uterus will have been removed in the vast majority of patients, for patients of child-bearing potential: negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. Patients will be considered of non-reproductive potential if they are either: - Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age, a high follicle stimulating hormone [FSH] level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR - Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion at least 6 weeks prior to registration - Have a congenital or acquired condition that prevents childbearing - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression - The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Exclusion Criteria

  • Prior Therapy: - Patients must NOT have received prior chemotherapy, biologic therapy, or targeted therapy for treatment of endometrial carcinoma - Patients must NOT have received prior radiation therapy for treatment of endometrial carcinoma. Prior radiation includes external beam pelvic radiation therapy, external beam extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy - NOTE: Vaginal brachytherapy for treatment of endometrial cancer is permitted during study treatment. Planned use of vaginal brachytherapy must be declared at time of registration - Patients may have received prior hormonal therapy for treatment of endometrial carcinoma. All hormonal therapy must be discontinued at least one week prior to registration - Patients may not have a planned interval cytoreduction or hysterectomy, prior to documentation of progression, after study registration - Patients may not have planned external beam radiotherapy, prior to documentation of progression, after study registration - Significant cardiovascular disease including: - Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg despite antihypertensive medications - Myocardial infarction or unstable angina within 6 months prior to registration - New York Heart Association functional classification II, III or IV - Serious cardiac arrhythmia requiring medication. This does not include asymptomatic, atrial fibrillation with controlled ventricular rate - Significant lung disease: dyspnea at rest grade 2 or greater (resulting from extensive tumor involvement or other causes), pneumonitis grade 2 or greater, interstitial lung disease grade 2 or greater, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia) - Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), uncontrolled interstitial lung disease, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements - Treatment with strong CYP2C8 or CYP3A4 inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to registration - Women who are unwilling to discontinue nursing

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm I (paclitaxel, carboplatin) 		Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. Patients undergo ECHO or MUGA and CT throughout the study. Additionally, patients may optionally undergo blood sample collection throughout the study, vaginal brachytherapy on study, and urine sample collection prior to treatment.
  • Procedure: Biospecimen Collection
    Undergo blood and urine sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Drug: Carboplatin
    Given IV
    Other names:
    • Blastocarb
    • Carboplat
    • Carboplatin Hexal
    • Carboplatino
    • Carboplatinum
    • Carbosin
    • Carbosol
    • Carbotec
    • CBDCA
    • Displata
    • Ercar
    • JM-8
    • JM8
    • Nealorin
    • Novoplatinum
    • Paraplatin
    • Paraplatin AQ
    • Paraplatine
    • Platinwas
    • Ribocarbo
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Procedure: Echocardiography
    Undergo ECHO
    Other names:
    • EC
  • Radiation: High-Dose-Rate Vaginal Cuff Brachytherapy
    Undergo vaginal brachytherapy
    Other names:
    • HDR-VCB
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • MUGA
    • Radionuclide Ventriculography
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
  • Drug: Paclitaxel
    Given IV
    Other names:
    • Anzatax
    • Asotax
    • Bristaxol
    • Praxel
    • Taxol
    • Taxol Konzentrat
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
Experimental
Arm II (paclitaxel, carboplatin, Herceptin Hylecta) 		Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30-60 minutes, and trastuzumab/hyaluronidase-oysk SC over 2-5 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. MAINTENANCE: Patients receive trastuzumab/hyaluronidase-oysk SC over 2-5 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients with SD or PR may continue maintenance therapy for up to 3 years from the start of treatment. Patients undergo ECHO or MUGA and CT throughout the study. Additionally patients may optionally undergo blood sample collection throughout the study, vaginal brachytherapy on study, and urine sample collection prior to treatment.
  • Procedure: Biospecimen Collection
    Undergo blood and urine sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Drug: Carboplatin
    Given IV
    Other names:
    • Blastocarb
    • Carboplat
    • Carboplatin Hexal
    • Carboplatino
    • Carboplatinum
    • Carbosin
    • Carbosol
    • Carbotec
    • CBDCA
    • Displata
    • Ercar
    • JM-8
    • JM8
    • Nealorin
    • Novoplatinum
    • Paraplatin
    • Paraplatin AQ
    • Paraplatine
    • Platinwas
    • Ribocarbo
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Procedure: Echocardiography
    Undergo ECHO
    Other names:
    • EC
  • Radiation: High-Dose-Rate Vaginal Cuff Brachytherapy
    Undergo vaginal brachytherapy
    Other names:
    • HDR-VCB
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • MUGA
    • Radionuclide Ventriculography
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
  • Drug: Paclitaxel
    Given IV
    Other names:
    • Anzatax
    • Asotax
    • Bristaxol
    • Praxel
    • Taxol
    • Taxol Konzentrat
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Drug: Trastuzumab/Hyaluronidase-oysk
    Given SC
    Other names:
    • Herceptin Hylecta
    • Trastuzumab and Hyaluronidase
    • Trastuzumab and Hyaluronidase-oysk
    • Trastuzumab and Recombinant Human Hyaluronidase PH20
    • Trastuzumab and rHuPH20
    • Trastuzumab-Hyaluronidase-oysk
Experimental
Arm III (paclitaxel, carboplatin, Phesgo) 		Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30-60 minutes, and pertuzumab/trastuzumab/hyaluronidase-zzxf SC over 5-8 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. MAINTENANCE: Patients receive pertuzumab/trastuzumab/ hyaluronidase-zzxf SC over 5 minutes on day 1. Cycles repeat every 3 weeks for up to 1 year in absence of disease progression or unacceptable toxicity. Patients with SD or PR may continue maintenance for up to 3 years from the start of treatment. Patients undergo ECHO or MUGA and CT throughout the study. Additionally, patients may optionally undergo blood sample collection throughout the study, vaginal brachytherapy on study, and urine sample collection prior to treatment.
  • Procedure: Biospecimen Collection
    Undergo blood and urine sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Drug: Carboplatin
    Given IV
    Other names:
    • Blastocarb
    • Carboplat
    • Carboplatin Hexal
    • Carboplatino
    • Carboplatinum
    • Carbosin
    • Carbosol
    • Carbotec
    • CBDCA
    • Displata
    • Ercar
    • JM-8
    • JM8
    • Nealorin
    • Novoplatinum
    • Paraplatin
    • Paraplatin AQ
    • Paraplatine
    • Platinwas
    • Ribocarbo
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Procedure: Echocardiography
    Undergo ECHO
    Other names:
    • EC
  • Radiation: High-Dose-Rate Vaginal Cuff Brachytherapy
    Undergo vaginal brachytherapy
    Other names:
    • HDR-VCB
  • Drug: Hyaluronidase-zzxf/Pertuzumab/Trastuzumab
    Given SC
    Other names:
    • Pertuzumab and Trastuzumab hyaluronidase
    • Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf
    • Pertuzumab/Trastuzumab/Hyaluronidase-zzxf
    • Phesgo
  • Procedure: Multigated Acquisition Scan
    Undergo MUGA
    Other names:
    • Blood Pool Scan
    • Equilibrium Radionuclide Angiography
    • Gated Blood Pool Imaging
    • MUGA
    • Radionuclide Ventriculography
    • RNVG
    • SYMA Scanning
    • Synchronized Multigated Acquisition Scanning
  • Drug: Paclitaxel
    Given IV
    Other names:
    • Anzatax
    • Asotax
    • Bristaxol
    • Praxel
    • Taxol
    • Taxol Konzentrat
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment

Recruiting Locations

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Contact:
Site Public Contact
205-934-0220
tmyrick@uab.edu

Banner University Medical Center - Tucson
Tucson, Arizona 85719
Contact:
Site Public Contact
UACC-IIT@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
Contact:
Site Public Contact
UACC-IIT@uacc.arizona.edu

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Sutter Auburn Faith Hospital
Auburn, California 95602
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

City of Hope Comprehensive Cancer Center
Duarte, California 91010
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

City of Hope Seacliff
Huntington Beach, California 92648
Contact:
Site Public Contact
626-256-4673

City of Hope at Irvine Lennar
Irvine, California 92618
Contact:
Site Public Contact
877-467-3411

Kaiser Permanente-Irvine
Irvine, California 92618
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

City of Hope at Long Beach Elm
Long Beach, California 90813
Contact:
Site Public Contact
877-467-3411

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Memorial Medical Center
Modesto, California 95355
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California 94040
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Kaiser Permanente - Panorama City
Panorama City, California 91402
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Riverside
Riverside, California 92505
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Sutter Roseville Medical Center
Roseville, California 95661
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089

California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

City of Hope Upland
Upland, California 91786
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

John Muir Medical Center-Walnut Creek
Walnut Creek, California 94598
Contact:
Site Public Contact
925-941-4246
clinicalresearch@johnmuirhealth.com

UCHealth University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650

UCHealth - Cherry Creek
Denver, Colorado 80206
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Banner North Colorado Medical Center
Greeley, Colorado 80631
Contact:
Site Public Contact
970-810-3046
BMDACCResearchCOMailbox@bannerhealth.com

UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
Contact:
Site Public Contact
720-848-0650

Banner McKee Medical Center
Loveland, Colorado 80539
Contact:
Site Public Contact
970-810-3046
BMDACCResearchCOMailbox@bannerhealth.com

Danbury Hospital
Danbury, Connecticut 06810
Contact:
Site Public Contact
203-739-8074

Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut 06418
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut 06824
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut 06033
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut 06830
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut 06437
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut 06105
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Yale University
New Haven, Connecticut 06520
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut 06473
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Norwalk Hospital
Norwalk, Connecticut 06856
Contact:
Site Public Contact
203-852-2996
jennifer.long@norwalkhealth.org

Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut 06902
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut 06790
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Helen F Graham Cancer Center
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Sibley Memorial Hospital
Washington, District of Columbia 20016
Contact:
Site Public Contact
202-243-2373
jquiver1@jhmi.edu

George Washington University Medical Center
Washington, District of Columbia 20037
Contact:
Site Public Contact
202-741-2981

Broward Health Medical Center
Fort Lauderdale, Florida 33316
Contact:
Site Public Contact
302-651-5572
Allison.bruce@nemours.org

Sarasota Memorial Hospital-Venice
N. Venice, Florida 34275
Contact:
Site Public Contact
941-261-9000

AdventHealth Orlando
Orlando, Florida 32803
Contact:
Site Public Contact
407-303-2090
FH.Cancer.Research@flhosp.org

Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida 34236
Contact:
Site Public Contact
941-957-1000

First Physicians Group-Sarasota
Sarasota, Florida 34239
Contact:
Site Public Contact
941-917-8383

Sarasota Memorial Hospital
Sarasota, Florida 34239
Contact:
Site Public Contact
941-917-2225

Florida Cancer Specialists - Venice Healthpark
Venice, Florida 34292
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Grady Health System
Atlanta, Georgia 30303
Contact:
Site Public Contact
404-489-9164

Emory University Hospital Midtown
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868

Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Contact:
Site Public Contact
404-851-7115

Augusta University Medical Center
Augusta, Georgia 30912
Contact:
Site Public Contact
706-721-2388
ga_cares@augusta.edu

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Contact:
Site Public Contact
912-819-5704
underberga@sjchs.org

Queen's Medical Center
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-545-8548

Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
Contact:
Site Public Contact
808-983-6090

Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Northwest Community Hospital
Arlington Heights, Illinois 60005
Contact:
Site Public Contact
847-618-4968

Rush - Copley Medical Center
Aurora, Illinois 60504
Contact:
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

Centralia Oncology Clinic
Centralia, Illinois 62801
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

John H Stroger Jr Hospital of Cook County
Chicago, Illinois 60612
Contact:
Site Public Contact
312-864-5204

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Site Public Contact
312-942-5498
clinical_trials@rush.edu

University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Carle at The Riverfront
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Carle Physician Group-Effingham
Effingham, Illinois 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109

Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109

Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
Contact:
Site Public Contact
312-695-1102

Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
Contact:
Site Public Contact
312-695-1102

NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Contact:
Site Public Contact
847-570-2109

Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Contact:
Site Public Contact
cancertrials@northwestern.edu

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541

Springfield Memorial Hospital
Springfield, Illinois 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Rush-Copley Healthcare Center
Yorkville, Illinois 60560
Contact:
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

IU Health North Hospital
Carmel, Indiana 46032
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

Northwest Cancer Center - Main Campus
Crown Point, Indiana 46307
Contact:
Site Public Contact
219-310-2550

Northwest Oncology LLC
Dyer, Indiana 46311
Contact:
Site Public Contact
219-924-8178

Goshen Center for Cancer Care
Goshen, Indiana 46526
Contact:
Site Public Contact
574-364-2973
cccois@goshenhealth.com

Northwest Cancer Center - Hobart
Hobart, Indiana 46342
Contact:
Site Public Contact
219-947-1795

Saint Mary Medical Center
Hobart, Indiana 46342
Contact:
Site Public Contact
219-836-6875
CancerResearch@COMHS.org

Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana 46260
Contact:
Site Public Contact
317-338-2194
research@stvincent.org

Saint Catherine Hospital
Indianapolis, Indiana 46312
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Franciscan Saint Elizabeth Health - Lafayette East
Lafayette, Indiana 47905
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

The Community Hospital
Munster, Indiana 46321
Contact:
Site Public Contact
219-836-3349

Women's Diagnostic Center - Munster
Munster, Indiana 46321
Contact:
Site Public Contact
219-934-8869
mnicholson@comhs.org

Northwest Cancer Center - Valparaiso
Valparaiso, Indiana 46383
Contact:
Site Public Contact
219-836-6875
CancerResearch@COMHS.org

Mary Greeley Medical Center
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132

McFarland Clinic - Ames
Ames, Iowa 50010
Contact:
Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com

McFarland Clinic - Boone
Boone, Iowa 50036
Contact:
Site Public Contact
515-956-4132

Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
Council Bluffs, Iowa 51503
Contact:
Site Public Contact
402-354-5892
Liza.brandes@nmhs.org

McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-956-4132

University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
Contact:
Site Public Contact
800-237-1225

McFarland Clinic - Jefferson
Jefferson, Iowa 50129
Contact:
Site Public Contact
515-956-4132

McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
Contact:
Site Public Contact
515-956-4132

Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky 41017
Contact:
Site Public Contact
859-301-4730
barbara.logan@stelizabeth.com

Baptist Health Lexington
Lexington, Kentucky 40503
Contact:
Site Public Contact
859-260-6425

Baptist Health Louisville
Louisville, Kentucky 40207
Contact:
Site Public Contact
502-897-8592
Cbcresearch@bhsi.com

Our Lady of the Lake Physician Group
Baton Rouge, Louisiana 70808
Contact:
Site Public Contact
225-765-7659
research@ololrmc.com

Our Lady of the Lake Medical Oncology
Baton Rouge, Louisiana 70817
Contact:
Site Public Contact
225-765-7659
research@ololrmc.com

Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana 70433
Contact:
Site Public Contact
985-809-5668
Cheryl.kesler@ochsner.org

East Jefferson General Hospital
Metairie, Louisiana 70006
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

University Medical Center New Orleans
New Orleans, Louisiana 70112
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Ochsner Baptist Medical Center
New Orleans, Louisiana 70115
Contact:
Site Public Contact
504-842-8084
Elisemarie.curry@ochsner.org

Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
Contact:
Site Public Contact
504-842-8084
Elisemarie.curry@ochsner.org

Harold Alfond Center for Cancer Care
Augusta, Maine 04330
Contact:
Site Public Contact
207-626-4855

Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
Contact:
Site Public Contact
207-396-8090
wrighd@mmc.org

Greater Baltimore Medical Center
Baltimore, Maryland 21204
Contact:
Site Public Contact
443-849-3706

Sinai Hospital of Baltimore
Baltimore, Maryland 21215
Contact:
Site Public Contact
410-601-6120
pridgely@lifebridgehealth.org

MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland 21237
Contact:
Site Public Contact
443-777-7364

Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
Contact:
Site Public Contact
410-955-8804
jhcccro@jhmi.edu

Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
Contact:
Site Public Contact
301-319-2100

William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland 21157
Contact:
Site Public Contact
410-871-6400

Baystate Medical Center
Springfield, Massachusetts 01199
Contact:
Site Public Contact
413-794-3565
tamara.wrenn@baystatehealth.org

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Genesee Hematology Oncology PC
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Genesys Hurley Cancer Institute
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Hurley Medical Center
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230

Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Contact:
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Corewell Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

MyMichigan Medical Center Saginaw
Saginaw, Michigan 48601
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

MyMichigan Medical Center Tawas
Tawas City, Michigan 48764
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

University of Michigan Health - West
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Mercy Hospital
Coon Rapids, Minnesota 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Fairview Southdale Hospital
Edina, Minnesota 55435
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
Contact:
Site Public Contact
612-624-2620

Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Regions Hospital
Saint Paul, Minnesota 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

United Hospital
Saint Paul, Minnesota 55102
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri 65212
Contact:
Site Public Contact
573-882-7440

Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
research@phelpshealth.org

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

CoxHealth South Hospital
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520

Billings Clinic Cancer Center
Billings, Montana 59101
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Saint Vincent Frontier Cancer Center
Billings, Montana 59102
Contact:
Site Public Contact
800-648-6274

Intermountain Health West End Clinic
Billings, Montana 59106
Contact:
Site Public Contact
406-238-6685

Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Logan Health Medical Center
Kalispell, Montana 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Center
Missoula, Montana 59804
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-334-4773

Nebraska Methodist Hospital
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-354-5144

Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
Contact:
Site Public Contact
702-693-6870
jamador@wccenter.com

OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592

Cooper Hospital University Medical Center
Camden, New Jersey 08103
Contact:
Site Public Contact
856-325-6757

Hackensack University Medical Center
Hackensack, New Jersey 07601
Contact:
Site Public Contact
551-996-2897

Monmouth Medical Center Southern Campus
Lakewood, New Jersey 08701
Contact:
Site Public Contact
732-923-6564
mary.danish@rwjbh.org

Saint Barnabas Medical Center
Livingston, New Jersey 07039
Contact:
Site Public Contact
973-322-2934
joanne.loeb@rwjbh.org

Monmouth Medical Center
Long Branch, New Jersey 07740
Contact:
Site Public Contact
732-923-6564
mary.danish@rwjbh.org

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592

Jersey Shore Medical Center
Neptune, New Jersey 07753
Contact:
Site Public Contact
732-776-4240

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356

Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey 07701
Contact:
Site Public Contact
732-530-2382

Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
Contact:
Site Public Contact
908-685-2481
Siby.Varughese@rwjbh.org

University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Presbyterian Kaseman Hospital
Albuquerque, New Mexico 87110
Contact:
Site Public Contact
505-559-6113
WBurman@phs.org

Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico 87124
Contact:
Site Public Contact
505-559-6113
WBurman@phs.org

Women's Cancer Care Associates LLC
Albany, New York 12208
Contact:
Site Public Contact
518-458-1390
jbarlin@womenscancercareassociates.com

Memorial Sloan Kettering Commack
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Westchester
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592

NYU Langone Hospital - Long Island
Mineola, New York 11501
Contact:
Site Public Contact
212-263-4432
cancertrials@nyulangone.org

Mount Sinai Chelsea
New York, New York 10011
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
Contact:
Site Public Contact
CancerTrials@nyulangone.org

Mount Sinai Hospital
New York, New York 10029
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Site Public Contact
212-639-7592

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

State University of New York Upstate Medical University
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476

Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592

Duke Cancer Institute Cary
Cary, North Carolina 27518
Contact:
Site Public Contact
919-781-7070

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853

ECU Health Medical Center
Greenville, North Carolina 27834
Contact:
Site Public Contact
252-744-2391
research@ecuhealth.org

Hayworth Cancer Center
High Point, North Carolina 27262
Contact:
Site Public Contact
336-802-2500

Duke Women's Cancer Care Raleigh
Raleigh, North Carolina 27607
Contact:
Site Public Contact
919-785-4878

Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-342-3000

Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771

UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Strecker Cancer Center-Belpre
Belpre, Ohio 45714
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Aultman Health Foundation
Canton, Ohio 44710
Contact:
Site Public Contact
330-363-7274
ClinicalReserachDept@aultman.com

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Geauga Hospital
Chardon, Ohio 44024
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Adena Regional Medical Center
Chillicothe, Ohio 45601
Contact:
Site Public Contact
877-779-7585
Jeffh@columbusccop.org

Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Site Public Contact
216-778-7559
ababal@metrohealth.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

Mount Carmel East Hospital
Columbus, Ohio 43213
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

The Mark H Zangmeister Center
Columbus, Ohio 43219
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Mount Carmel Grove City Hospital
Grove City, Ohio 43123
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Fairfield Medical Center
Lancaster, Ohio 43130
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Saint Rita's Medical Center
Lima, Ohio 45801
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Marietta Memorial Hospital
Marietta, Ohio 45750
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Memorial Hospital
Marysville, Ohio 43040
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Knox Community Hospital
Mount Vernon, Ohio 43050
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Licking Memorial Hospital
Newark, Ohio 43055
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio 43551
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Southern Ohio Medical Center
Portsmouth, Ohio 45662
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Springfield Regional Cancer Center
Springfield, Ohio 45504
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Springfield Regional Medical Center
Springfield, Ohio 45504
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

ProMedica Flower Hospital
Sylvania, Ohio 43560
Contact:
Site Public Contact
419-824-1842
PCIOncResearch@promedica.org

Mercy Health - Saint Vincent Hospital
Toledo, Ohio 43608
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health - Saint Anne Hospital
Toledo, Ohio 43623
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Saint Ann's Hospital
Westerville, Ohio 43081
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio 44145
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402

Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon 97015
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Newberg Medical Center
Newberg, Oregon 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
Contact:
Site Public Contact
800-220-4937
cancer@lhs.org

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland, Oregon 97225
Contact:
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503-215-2614
CanRsrchStudies@providence.org

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Site Public Contact
503-494-1080
trials@ohsu.edu

Legacy Meridian Park Hospital
Tualatin, Oregon 97062
Contact:
Site Public Contact
503-413-1742

Saint Luke's Cancer Center - Allentown
Allentown, Pennsylvania 18104
Contact:
Site Public Contact
610-776-4714

Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania 18015
Contact:
Site Public Contact
484-503-4151

Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Saint Luke's Hospital-Anderson Campus
Easton, Pennsylvania 18045
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Saint Vincent Hospital
Erie, Pennsylvania 16544
Contact:
Site Public Contact
814-452-5000

Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
Contact:
Site Public Contact
412-359-3043
ddefazio@wpahs.org

Riddle Memorial Hospital
Media, Pennsylvania 19063
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Forbes Hospital
Monroeville, Pennsylvania 15146
Contact:
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412-858-7746

Paoli Memorial Hospital
Paoli, Pennsylvania 19301
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Pennsylvania Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
855-216-0098
PennCancerTrials@careboxhealth.com

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
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215-728-4790

West Penn Hospital
Pittsburgh, Pennsylvania 15224
Contact:
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412-578-5000

Saint Luke's Hospital - Upper Bucks Campus
Quakertown, Pennsylvania 18951
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610-776-4714

Chester County Hospital
West Chester, Pennsylvania 19380
Contact:
Site Public Contact
610-431-5044
carolann.hoppes@pennmedicine.upenn.edu

Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
Contact:
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Dawnmarie.DeFazio@ahn.org

Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
Contact:
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215-600-9151
ONCTrialNow@jefferson.edu

Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Contact:
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484-476-2649
turzoe@mlhs.org

Women and Infants Hospital
Providence, Rhode Island 02905
Contact:
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401-274-1122

Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island 02891
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina 29910
Contact:
Site Public Contact
912-819-5704
underberga@sjchs.org

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu

Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota 57401
Contact:
Site Public Contact
605-622-8700
oncregulatory@avera.org

Avera Cancer Institute
Sioux Falls, South Dakota 57105
Contact:
Site Public Contact
605-322-3095
OncRegulatory@avera.org

Dell Seton Medical Center at The University of Texas
Austin, Texas 78701
Contact:
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512-324-7991

University of Texas at Austin
Austin, Texas 78712
Contact:
Site Public Contact
512-232-1543
irb@austin.utexas.edu

Parkland Memorial Hospital
Dallas, Texas 75235
Contact:
Site Public Contact
214-590-5582
canceranswerline@UTSouthwestern.edu

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

Houston Methodist Saint John Hospital
Nassau Bay, Texas 77058
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
Contact:
Site Public Contact
972-669-7044
Suzanne.cole@utsouthwestern.edu

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

South Jordan Health Center
South Jordan, Utah 84009
Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu

Henrico Doctor's Hospital
Richmond, Virginia 23229
Contact:
Site Public Contact
804-289-4902
chbgynonc@gmail.com

VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Contact:
Site Public Contact
ctoclinops@vcu.edu

Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Contact:
Site Public Contact
CTOclinops@vcu.edu

Carilion Clinic Gynecological Oncology
Roanoke, Virginia 24016
Contact:
Site Public Contact
540-985-8510

Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
Contact:
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206-215-3086
PCRC-NCORP@Swedish.org

Swedish Medical Center-First Hill
Seattle, Washington 98122
Contact:
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206-215-3086
PCRC-NCORP@Swedish.org

Legacy Salmon Creek Hospital
Vancouver, Washington 98686
Contact:
Site Public Contact
503-413-2150

West Virginia University Charleston Division
Charleston, West Virginia 25304
Contact:
Site Public Contact
304-388-9944

West Virginia University Healthcare
Morgantown, West Virginia 26506
Contact:
Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu

Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
Contact:
Site Public Contact
608-775-2385
cancerctr@gundersenhealth.org

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
Contact:
Site Public Contact
800-622-8922
clinicaltrials@cancer.wisc.edu

University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
Contact:
Site Public Contact
800-622-8922
clinicaltrials@cancer.wisc.edu

Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666

Marshfield Medical Center - Minocqua
Minocqua, Wisconsin 54548
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Contact:
Site Public Contact
research.institute@phci.org

Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Contact:
Site Public Contact
262-928-7878

Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin 54154
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
Contact:
Site Public Contact
262-928-5539
Chanda.miller@phci.org

Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Centro Comprensivo de Cancer de UPR
San Juan, Puerto Rico 00927
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

More Details

NCT ID
NCT05256225
Status
Recruiting
Sponsor
National Cancer Institute (NCI)

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial cancer. (Phase II) II. To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial cancer. (Phase III) SECONDARY OBJECTIVES: I. To evaluate the overall response rate (ORR) in patients with measurable disease. II. To evaluate the duration of objective response in patients with measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. III. To determine the nature, frequency and degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 for each treatment arm. IV. To compare quality of life (QOL), as measured by Functional Assessment of Cancer Therapy - Endometrial Trial Outcome Index (FACT-En-TOI), in the experimental versus control arms. V. To compare patient-reported treatment-associated symptoms (diarrhea and rash) as measured with the Patient Reported Outcomes (PRO) - CTCAE, patient-reported fatigue as measured with the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue short form, and worry concerning side effects of treatment as measured by the item 'bothered by side effect', in the FACT-En TOI, respectively, in the experimental and control arms. VI. To assess the correlation of HER2 immunohistochemistry (IHC) expression and in situ hybridization (ISH) amplification with clinical outcome and response to HER2 targeted therapies. EXPLORATORY OBJECTIVE: I. To explore time to sustained deterioration in quality of life, as measured by a drop in the FACT-En-TOI by 6 or more points lasting for more than one PRO time point, in the experimental and control arms. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease (SD) or partial response (PR) who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. ARM II: Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30-60 minutes, and trastuzumab/hyaluronidase-oysk subcutaneously (SC) over 2-5 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. MAINTENANCE: Patients receive trastuzumab/hyaluronidase-oysk SC over 2-5 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients with SD or PR may continue maintenance therapy for up to 3 years from the start of treatment. ARM III: Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30-60 minutes, and pertuzumab/trastuzumab/hyaluronidase-zzxf SC over 5-8 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease after completion of cycle 6 may receive 4 additional cycles of this treatment at the discretion of the treating physician. MAINTENANCE: Patients receive pertuzumab/trastuzumab/ hyaluronidase-zzxf SC over 5 minutes on day 1. Cycles repeat every 3 weeks for up to 1 year in absence of disease progression or unacceptable toxicity. Patients with SD or PR may continue maintenance for up to 3 years from the start of treatment. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) and computed tomography (CT) throughout the study. Additionally, patients may optionally undergo blood sample collection throughout the study, vaginal brachytherapy on study, and urine sample collection prior to treatment. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.