Testing the Addition of Trastuzumab or Trastuzumab/Pertuzumab to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma
Purpose
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma. 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 cancer 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 serous carcinoma or carcinosarcoma.
Conditions
- Endometrial Serous Adenocarcinoma
- 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 serous carcinoma or endometrial carcinosarcoma - 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 computed tomography (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 - Additionally, patients must have the following histologic types to be eligible: - Serous adenocarcinoma (may include =< 10% non-serous histology) - Carcinosarcoma with serous epithelial component (only the serous component needs to be HER2 positive; may include =< 10% non-serous histology) - In cases where determination of serous is equivocal or challenging, aberrant p53 immunohistochemistry (IHC) (defined as overexpression of p53 compared to internal controls) will be sufficient for inclusion - 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. In general HER2 positivity is defined as any of the following: - 3+ immunohistochemistry (IHC), - 2+ IHC with positive in situ hybridization (ISH) - Average HER2 copy number >= 6.0 signals/cell - Average HER2 copy number >= 4.0 and < 6.0 signals/cell, with concurrent IHC 3+ - HER2/CEP17 ratio >= 4.0 signals/cell - HER2/CEP 17 ratio >= 2.0 and < 4.0, with concurrent IHC 3+ IHC and ISH testing will be done locally, at each participating institution and interpreted by local pathologists. 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. NOTE: Patients with prior anthracycline exposure are NOT eligible - 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
| Arm | Description | Assigned 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 scan at end of treatment and every 6 months for 2 years. |
|
|
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 scan at end of treatment and every 6 months for 2 years. |
|
|
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 scan at end of treatment and every 6 months for 2 years. |
|
Recruiting Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Banner University Medical Center - Tucson
Tucson, Arizona 85719
Tucson, Arizona 85719
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
Tucson, Arizona 85719
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
Sutter Auburn Faith Hospital
Auburn, California 95602
Auburn, California 95602
John Muir Medical Center-Concord Campus
Concord, California 94520
Concord, California 94520
Contact:
Site Public Contact
925-674-2580
Site Public Contact
925-674-2580
City of Hope Comprehensive Cancer Center
Duarte, California 91010
Duarte, California 91010
City of Hope at Huntington Beach
Huntington Beach, California 92648
Huntington Beach, California 92648
Contact:
Site Public Contact
877-467-3411
Site Public Contact
877-467-3411
City of Hope at Irvine Lennar
Irvine, California 92618
Irvine, California 92618
Contact:
Site Public Contact
877-467-3411
Site Public Contact
877-467-3411
Kaiser Permanente-Irvine
Irvine, California 92618
Irvine, California 92618
City of Hope at Long Beach Elm
Long Beach, California 90813
Long Beach, California 90813
Contact:
Site Public Contact
877-467-3411
Site Public Contact
877-467-3411
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
Memorial Medical Center
Modesto, California 95355
Modesto, California 95355
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California 94040
Mountain View, California 94040
Kaiser Permanente-Riverside
Riverside, California 92505
Riverside, California 92505
Sutter Roseville Medical Center
Roseville, California 95661
Roseville, California 95661
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089
Site Public Contact
916-734-3089
California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
San Francisco, California 94115
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Sunnyvale, California 94086
City of Hope Upland
Upland, California 91786
Upland, California 91786
John Muir Medical Center-Walnut Creek
Walnut Creek, California 94598
Walnut Creek, California 94598
Contact:
Site Public Contact
925-941-4246
Site Public Contact
925-941-4246
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650
Site Public Contact
720-848-0650
UCHealth - Cherry Creek
Denver, Colorado 80206
Denver, Colorado 80206
North Colorado Medical Center
Greeley, Colorado 80631
Greeley, Colorado 80631
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
Highlands Ranch, Colorado 80129
Contact:
Site Public Contact
720-848-0650
Site Public Contact
720-848-0650
Danbury Hospital
Danbury, Connecticut 06810
Danbury, Connecticut 06810
Contact:
Site Public Contact
203-739-8074
Site Public Contact
203-739-8074
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut 06033
Glastonbury, Connecticut 06033
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut 06105
Hartford, Connecticut 06105
Yale University
New Haven, Connecticut 06520
New Haven, Connecticut 06520
Norwalk Hospital
Norwalk, Connecticut 06856
Norwalk, Connecticut 06856
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708
Waterbury, Connecticut 06708
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
Waterford, Connecticut 06385
Helen F Graham Cancer Center
Newark, Delaware 19713
Newark, Delaware 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Newark, Delaware 19713
Sibley Memorial Hospital
Washington, District of Columbia 20016
Washington, District of Columbia 20016
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida 34236
Sarasota, Florida 34236
Contact:
Site Public Contact
941-957-1000
Site Public Contact
941-957-1000
First Physicians Group-Sarasota
Sarasota, Florida 34239
Sarasota, Florida 34239
Contact:
Site Public Contact
941-917-8383
Site Public Contact
941-917-8383
Sarasota Memorial Hospital
Sarasota, Florida 34239
Sarasota, Florida 34239
Contact:
Site Public Contact
941-917-2225
Site Public Contact
941-917-2225
Florida Cancer Specialists - Venice Healthpark
Venice, Florida 34292
Venice, Florida 34292
Grady Health System
Atlanta, Georgia 30303
Atlanta, Georgia 30303
Contact:
Site Public Contact
404-489-9164
Site Public Contact
404-489-9164
Emory University Hospital Midtown
Atlanta, Georgia 30308
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447
Site Public Contact
888-946-7447
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868
Site Public Contact
404-778-1868
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Contact:
Site Public Contact
404-851-7115
Site Public Contact
404-851-7115
Augusta University Medical Center
Augusta, Georgia 30912
Augusta, Georgia 30912
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Savannah, Georgia 31405
Queen's Medical Center
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-545-8548
Site Public Contact
808-545-8548
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
Honolulu, Hawaii 96826
Contact:
Site Public Contact
808-983-6090
Site Public Contact
808-983-6090
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Boise, Idaho 83706
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Caldwell, Idaho 83605
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Coeur d'Alene, Idaho 83814
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
Nampa, Idaho 83686
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Nampa, Idaho 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Post Falls, Idaho 83854
Kootenai Cancer Clinic
Sandpoint, Idaho 83864
Sandpoint, Idaho 83864
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Twin Falls, Idaho 83301
Northwest Community Hospital
Arlington Heights, Illinois 60005
Arlington Heights, Illinois 60005
Contact:
Site Public Contact
847-618-4968
Site Public Contact
847-618-4968
Rush - Copley Medical Center
Aurora, Illinois 60504
Aurora, Illinois 60504
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Site Public Contact
312-864-5204
Site Public Contact
312-864-5204
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
DeKalb, Illinois 60115
Carle Physician Group-Effingham
Effingham, Illinois 62401
Effingham, Illinois 62401
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Geneva, Illinois 60134
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Highland Park, Illinois 60035
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois 60521
Hinsdale, Illinois 60521
Contact:
Site Public Contact
630-856-6757
Site Public Contact
630-856-6757
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Lake Forest, Illinois 60045
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Mattoon, Illinois 61938
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
New Lenox, Illinois 60451
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Orland Park, Illinois 60462
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Memorial Medical Center
Springfield, Illinois 62781
Springfield, Illinois 62781
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Warrenville, Illinois 60555
Rush-Copley Healthcare Center
Yorkville, Illinois 60560
Yorkville, Illinois 60560
Northwest Cancer Center - Main Campus
Crown Point, Indiana 46307
Crown Point, Indiana 46307
Contact:
Site Public Contact
219-310-2550
Site Public Contact
219-310-2550
Northwest Oncology LLC
Dyer, Indiana 46311
Dyer, Indiana 46311
Contact:
Site Public Contact
219-924-8178
Site Public Contact
219-924-8178
Goshen Center for Cancer Care
Goshen, Indiana 46526
Goshen, Indiana 46526
Northwest Cancer Center - Hobart
Hobart, Indiana 46342
Hobart, Indiana 46342
Contact:
Site Public Contact
219-947-1795
Site Public Contact
219-947-1795
Saint Mary Medical Center
Hobart, Indiana 46342
Hobart, Indiana 46342
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Franciscan Health Indianapolis
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
Contact:
Site Public Contact
317-528-7060
Site Public Contact
317-528-7060
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
Saint Catherine Hospital
Indianapolis, Indiana 46312
Indianapolis, Indiana 46312
Franciscan Health Mooresville
Mooresville, Indiana 46158
Mooresville, Indiana 46158
Contact:
Site Public Contact
317-834-3603
Site Public Contact
317-834-3603
The Community Hospital
Munster, Indiana 46321
Munster, Indiana 46321
Contact:
Site Public Contact
219-836-3349
Site Public Contact
219-836-3349
Women's Diagnostic Center - Munster
Munster, Indiana 46321
Munster, Indiana 46321
Memorial Hospital of South Bend
South Bend, Indiana 46601
South Bend, Indiana 46601
Contact:
Site Public Contact
800-284-7370
Site Public Contact
800-284-7370
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana 46383
Valparaiso, Indiana 46383
Mary Greeley Medical Center
Ames, Iowa 50010
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Ames
Ames, Iowa 50010
Ames, Iowa 50010
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Contact:
Site Public Contact
800-237-1225
Site Public Contact
800-237-1225
McFarland Clinic - Jefferson
Jefferson, Iowa 50129
Jefferson, Iowa 50129
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
Marshalltown, Iowa 50158
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky 41017
Edgewood, Kentucky 41017
Baptist Health Lexington
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Contact:
Site Public Contact
859-260-6425
Site Public Contact
859-260-6425
Baptist Health Louisville
Louisville, Kentucky 40207
Louisville, Kentucky 40207
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana 70805
Baton Rouge, Louisiana 70805
Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
Our Lady of the Lake Medical Oncology
Baton Rouge, Louisiana 70817
Baton Rouge, Louisiana 70817
East Jefferson General Hospital
Metairie, Louisiana 70006
Metairie, Louisiana 70006
University Medical Center New Orleans
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Ochsner Baptist Medical Center
New Orleans, Louisiana 70115
New Orleans, Louisiana 70115
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
Scarborough, Maine 04074
Greater Baltimore Medical Center
Baltimore, Maryland 21204
Baltimore, Maryland 21204
Contact:
Site Public Contact
443-849-3706
Site Public Contact
443-849-3706
Sinai Hospital of Baltimore
Baltimore, Maryland 21215
Baltimore, Maryland 21215
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
Bethesda, Maryland 20889-5600
Contact:
Site Public Contact
301-319-2100
Site Public Contact
301-319-2100
William E Kahlert Regional Cancer Center/Sinai Hospital
Westminster, Maryland 21157
Westminster, Maryland 21157
Contact:
Site Public Contact
410-871-6400
Site Public Contact
410-871-6400
Baystate Medical Center
Springfield, Massachusetts 01199
Springfield, Massachusetts 01199
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125
Site Public Contact
800-865-1125
Bronson Battle Creek
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Detroit, Michigan 48201
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
Beaumont Hospital - Farmington Hills
Farmington Hills, Michigan 48336
Farmington Hills, Michigan 48336
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
West Michigan Cancer Center
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
Kalamazoo, Michigan 49009
Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Muskegon, Michigan 49444
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Norton Shores, Michigan 49444
Spectrum Health Reed City Hospital
Reed City, Michigan 49677
Reed City, Michigan 49677
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan 48073
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Munson Medical Center
Traverse City, Michigan 49684
Traverse City, Michigan 49684
William Beaumont Hospital - Troy
Troy, Michigan 48085
Troy, Michigan 48085
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
University of Michigan Health - West
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
Contact:
Site Public Contact
612-624-2620
Site Public Contact
612-624-2620
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri 65212
Columbia, Missouri 65212
Contact:
Site Public Contact
573-882-7440
Site Public Contact
573-882-7440
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Rolla, Missouri 65401
Washington University School of Medicine
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
CoxHealth South Hospital
Springfield, Missouri 65807
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Community Hospital of Anaconda
Anaconda, Montana 59711
Anaconda, Montana 59711
Billings Clinic Cancer Center
Billings, Montana 59101
Billings, Montana 59101
Bozeman Deaconess Hospital
Bozeman, Montana 59715
Bozeman, Montana 59715
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Great Falls, Montana 59405
Kalispell Regional Medical Center
Kalispell, Montana 59901
Kalispell, Montana 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana 59802
Missoula, Montana 59802
Community Medical Hospital
Missoula, Montana 59804
Missoula, Montana 59804
Nebraska Methodist Hospital
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-354-5144
Site Public Contact
402-354-5144
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Omaha, Nebraska 68124
OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Monmouth Medical Center Southern Campus
Lakewood, New Jersey 08701
Lakewood, New Jersey 08701
Saint Barnabas Medical Center
Livingston, New Jersey 07039
Livingston, New Jersey 07039
Monmouth Medical Center
Long Branch, New Jersey 07740
Long Branch, New Jersey 07740
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Virtua Samson Cancer Center
Moorestown, New Jersey 08057
Moorestown, New Jersey 08057
Contact:
Site Public Contact
856-247-7395
Site Public Contact
856-247-7395
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356
Site Public Contact
732-235-7356
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
Somerville, New Jersey 08876
Virtua Voorhees
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
Contact:
Site Public Contact
856-247-7395
Site Public Contact
856-247-7395
University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
Presbyterian Kaseman Hospital
Albuquerque, New Mexico 87110
Albuquerque, New Mexico 87110
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico 87124
Rio Rancho, New Mexico 87124
Memorial Sloan Kettering Commack
Commack, New York 11725
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Westchester
Harrison, New York 10604
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
NYU Winthrop Hospital
Mineola, New York 11501
Mineola, New York 11501
Mount Sinai Chelsea
New York, New York 10011
New York, New York 10011
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
New York, New York 10016
Mount Sinai Hospital
New York, New York 10029
New York, New York 10029
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830
Site Public Contact
585-275-5830
State University of New York Upstate Medical University
Syracuse, New York 13210
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476
Site Public Contact
315-464-5476
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Duke Cancer Institute Cary
Cary, North Carolina 27518
Cary, North Carolina 27518
Contact:
Site Public Contact
919-781-7070
Site Public Contact
919-781-7070
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Duke University Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853
Site Public Contact
888-275-3853
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-342-3000
Site Public Contact
910-342-3000
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771
Site Public Contact
336-713-6771
Sanford Broadway Medical Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Beachwood, Ohio 44122
Strecker Cancer Center-Belpre
Belpre, Ohio 45714
Belpre, Ohio 45714
Aultman Health Foundation
Canton, Ohio 44710
Canton, Ohio 44710
Miami Valley Hospital South
Centerville, Ohio 45459
Centerville, Ohio 45459
Geauga Hospital
Chardon, Ohio 44024
Chardon, Ohio 44024
Adena Regional Medical Center
Chillicothe, Ohio 45601
Chillicothe, Ohio 45601
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Cincinnati, Ohio 45220
Case Western Reserve University
Cleveland, Ohio 44106
Cleveland, Ohio 44106
MetroHealth Medical Center
Cleveland, Ohio 44109
Cleveland, Ohio 44109
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Mount Carmel East Hospital
Columbus, Ohio 43213
Columbus, Ohio 43213
Riverside Methodist Hospital
Columbus, Ohio 43214
Columbus, Ohio 43214
The Mark H Zangmeister Center
Columbus, Ohio 43219
Columbus, Ohio 43219
Miami Valley Hospital
Dayton, Ohio 45409
Dayton, Ohio 45409
Mount Carmel Grove City Hospital
Grove City, Ohio 43123
Grove City, Ohio 43123
Fairfield Medical Center
Lancaster, Ohio 43130
Lancaster, Ohio 43130
Saint Rita's Medical Center
Lima, Ohio 45801
Lima, Ohio 45801
Contact:
Site Public Contact
419-226-9617
Site Public Contact
419-226-9617
Marietta Memorial Hospital
Marietta, Ohio 45750
Marietta, Ohio 45750
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
Mentor, Ohio 44060
Knox Community Hospital
Mount Vernon, Ohio 43050
Mount Vernon, Ohio 43050
Licking Memorial Hospital
Newark, Ohio 43055
Newark, Ohio 43055
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio 43551
Perrysburg, Ohio 43551
Southern Ohio Medical Center
Portsmouth, Ohio 45662
Portsmouth, Ohio 45662
Springfield Regional Cancer Center
Springfield, Ohio 45504
Springfield, Ohio 45504
Springfield Regional Medical Center
Springfield, Ohio 45505
Springfield, Ohio 45505
ProMedica Flower Hospital
Sylvania, Ohio 43560
Sylvania, Ohio 43560
Saint Vincent Mercy Medical Center
Toledo, Ohio 43608
Toledo, Ohio 43608
Mercy Health - Saint Anne Hospital
Toledo, Ohio 43623
Toledo, Ohio 43623
Saint Ann's Hospital
Westerville, Ohio 43081
Westerville, Ohio 43081
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio 44145
Westlake, Ohio 44145
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
Zanesville, Ohio 43701
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma 74146
Tulsa, Oklahoma 74146
Contact:
Site Public Contact
918-505-3200
Site Public Contact
918-505-3200
Providence Newberg Medical Center
Newberg, Oregon 97132
Newberg, Oregon 97132
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
Ontario, Oregon 97914
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
Portland, Oregon 97210
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Oregon Health and Science University
Portland, Oregon 97239
Portland, Oregon 97239
Legacy Meridian Park Hospital
Tualatin, Oregon 97062
Tualatin, Oregon 97062
Contact:
Site Public Contact
503-413-1742
Site Public Contact
503-413-1742
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
Bryn Mawr, Pennsylvania 19010
Saint Vincent Hospital
Erie, Pennsylvania 16544
Erie, Pennsylvania 16544
Contact:
Site Public Contact
814-452-5000
Site Public Contact
814-452-5000
Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
Jefferson Hills, Pennsylvania 15025
Riddle Memorial Hospital
Media, Pennsylvania 19063
Media, Pennsylvania 19063
Forbes Hospital
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
Contact:
Site Public Contact
412-858-7746
Site Public Contact
412-858-7746
Paoli Memorial Hospital
Paoli, Pennsylvania 19301
Paoli, Pennsylvania 19301
Pennsylvania Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
800-789-7366
Site Public Contact
800-789-7366
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
West Penn Hospital
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
Contact:
Site Public Contact
412-578-5000
Site Public Contact
412-578-5000
Chester County Hospital
West Chester, Pennsylvania 19380
West Chester, Pennsylvania 19380
Contact:
Site Public Contact
610-431-5297
Site Public Contact
610-431-5297
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
Wexford, Pennsylvania 15090
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
Willow Grove, Pennsylvania 19090
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
Women and Infants Hospital
Providence, Rhode Island 02905
Providence, Rhode Island 02905
Contact:
Site Public Contact
401-274-1122
Site Public Contact
401-274-1122
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina 29910
Bluffton, South Carolina 29910
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota 57401
Aberdeen, South Dakota 57401
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Avera Cancer Institute
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
The West Clinic - Wolf River
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Dell Seton Medical Center at The University of Texas
Austin, Texas 78701
Austin, Texas 78701
Contact:
Site Public Contact
512-324-7991
Site Public Contact
512-324-7991
Parkland Memorial Hospital
Dallas, Texas 75235
Dallas, Texas 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Dallas, Texas 75390
Houston Methodist Hospital
Houston, Texas 77030
Houston, Texas 77030
Contact:
Site Public Contact
713-790-2700
Site Public Contact
713-790-2700
Methodist Willowbrook Hospital
Houston, Texas 77070
Houston, Texas 77070
Houston Methodist West Hospital
Houston, Texas 77094
Houston, Texas 77094
Contact:
Site Public Contact
832-522-2873
Site Public Contact
832-522-2873
Houston Methodist Saint John Hospital
Nassau Bay, Texas 77058
Nassau Bay, Texas 77058
Houston Methodist Sugar Land Hospital
Sugar Land, Texas 77479
Sugar Land, Texas 77479
Contact:
Site Public Contact
281-242-2873
Site Public Contact
281-242-2873
Houston Methodist The Woodlands Hospital
The Woodlands, Texas 77385
The Woodlands, Texas 77385
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
South Jordan Health Center
South Jordan, Utah 84009
South Jordan, Utah 84009
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Richmond, Virginia 23235
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Richmond, Virginia 23298
Carilion Clinic Gynecological Oncology
Roanoke, Virginia 24016
Roanoke, Virginia 24016
Contact:
Site Public Contact
540-985-8510
Site Public Contact
540-985-8510
Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
Edmonds, Washington 98026
Swedish Medical Center-First Hill
Seattle, Washington 98122
Seattle, Washington 98122
Legacy Salmon Creek Hospital
Vancouver, Washington 98686
Vancouver, Washington 98686
Contact:
Site Public Contact
503-413-2150
Site Public Contact
503-413-2150
West Virginia University Charleston Division
Charleston, West Virginia 25304
Charleston, West Virginia 25304
Contact:
Site Public Contact
304-388-9944
Site Public Contact
304-388-9944
West Virginia University Healthcare
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Contact:
Site Public Contact
800-622-8922
Site Public Contact
800-622-8922
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666
Site Public Contact
414-805-3666
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Mukwonago, Wisconsin 53149
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
New Richmond, Wisconsin 54017
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Oconomowoc, Wisconsin 53066
Contact:
Site Public Contact
262-928-7878
Site Public Contact
262-928-7878
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin 54154
Oconto Falls, Wisconsin 54154
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Sturgeon Bay, Wisconsin 54235-1495
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
Waukesha, Wisconsin 53188
Centro Comprensivo de Cancer de UPR
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00927
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 serous carcinoma or carcinosarcoma. (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 serous carcinoma or carcinosarcoma. (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 other 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 echocardiogram (ECHO) or multigated acquisition scan (MUGA) scan at end of treatment and every 6 months for 2 years. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.