Purpose

This randomized phase III trial studies cabozantinib S-malate to see how well it works compared with placebo in treating patients with neuroendocrine tumors previously treated with everolimus that have spread to nearby tissues or lymph nodes, have spread to other places in the body, or cannot be removed by surgery. Cabozantinib S-malate is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

Conditions

Eligibility

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

Criteria


Inclusion Criteria:

- Documentation of Disease:

- Histologic Documentation: Well- or moderately-differentiated neuroendocrine
tumors of pancreatic and non-pancreatic (i.e. carcinoid) origin by local
pathology

- The pathology report must state ONE of the following: 1) well- or
moderately-differentiated neuroendocrine tumor, 2) low- or
intermediate-grade neuroendocrine tumor, or 3) carcinoid tumor or atypical
carcinoid tumor; documentation of histology from a primary or metastatic
site is allowed

- Patients with poorly differentiated neuroendocrine carcinoma, high-grade
neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid
tumor are not eligible

- Stage: Locally advanced/unresectable or metastatic disease

- Tumor Site: Histological documentation of neuroendocrine tumor of pancreatic,
gastrointestinal (GI), lung, or unknown primary site; GI, lung, and unknown
primary NETs will enroll in the carcinoid tumor cohort of the study

- Functional (associated with a clinical hormone syndrome) or nonfunctional
tumors are allowed

- Radiologic Evaluation: Target lesions must have shown evidence of disease
progression by Response Evaluation Criteria in Solid Tumors (RECIST) version
(v)1.1 criteria in the 12 months prior to registration; the radiologic images,
imaging reports, and clinic notes indicating growth of existing lesions,
development of new lesions, or treatment changes must be submitted

- Measurable Disease

- Patients must have measurable disease per RECIST 1.1 by computer tomography (CT)
scan or magnetic resonance imaging (MRI)

- Lesions must be accurately measured in at least one dimension (longest diameter
to be recorded) as >= 1 cm with CT or MRI (or >= 1.5 cm for lymph nodes);
non-measurable disease includes disease smaller than these dimensions or lesions
considered truly non-measurable including: leptomeningeal disease, ascites,
pleural or pericardial effusion, lymphangitic involvement of skin or lung

- Prior Treatment

- Patient must have failed at least one prior systemic therapy that included
everolimus; disease progression or treatment intolerance leading to
discontinuation is considered treatment failure

- Prior treatment (except somatostatin analogs) with biologic therapy,
immunotherapy, chemotherapy, investigational agent for malignancy, and/or
radiation must be completed at least 28 days prior to registration

- Prior treatment with somatostatin analogs is allowed, and continuation of
treatment with somatostatin analogs while on cabozantinib/placebo is allowed
provided that the patient has been on a stable dose for at least two months

- Prior systemic treatment with radionuclide therapy must be completed at least 6
weeks prior to registration

- Prior treatment with hepatic artery embolization (including bland embolization,
chemoembolization, and selective internal radiation therapy) or ablative
therapies is allowed if measurable disease remains outside of the treated area or
if there is documented disease progression in a treated site; prior
liver-directed or other ablative treatment must be completed at least 28 days
prior to registration

- Prior treatment with cabozantinib is not allowed

- Patients should have resolution of any toxic effects of prior therapy (except
alopecia and fatigue) to National Cancer Institute (NCI) CTCAE, version 5.0,
grade 1 or less

- Patients must have completed any major surgery at least 12 weeks prior to
registration and any minor surgery (including uncomplicated tooth extractions) at
least 28 days prior to registration; complete wound healing from major surgery
must have occurred at least 28 days prior to registration, and complete wound
healing from minor surgery must have occurred at least 10 days prior to
registration

- Patient History

- No class III or IV congestive heart failure (CHF) within 6 months of registration

- No clinically significant cardiac arrhythmia within 6 months of registration

- No unstable angina or MI within 6 months of registration

- No thromboembolic events within 6 months of registration (including [incl.]
stroke, transient ischemic attack [TIA], deep vein thrombosis [DVT], & pulmonary
embolism [PE])

- No known history of congenital long QT syndrome

- No uncontrolled hypertension within 14 days of registration (defined as systolic
blood pressure [SBP] >= 150 mmHg and/or diastolic blood pressure [DBP] >= 90 mmHg
despite optimal medical management)

- No clinically significant GI bleeding within 6 months of registration

- No clinically significant gastrointestinal abnormalities that may increase the
risk for gastrointestinal bleeding within 6 months of registration including, but
not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with
history of bleeding, inflammatory bowel disease, or other gastrointestinal
conditions with increased risk of perforation

- No GI perforation within 6 months of registration

- No known tumor invading the GI tract within 28 days of registration

- No radiologic or clinical evidence of pancreatitis

- No known cavitary lung lesions

- No known endobronchial lesions involving the main or lobar bronchi and/or lesions
infiltrating major pulmonary vessels that increase the risk of pulmonary
hemorrhage; (CT with contrast is recommended to evaluate such lesions)

- No hemoptysis greater than 1/2 teaspoon (2.5 mL) or any other signs of pulmonary
hemorrhage within the 3 months prior to registration

- No known tumor invading or encasing any major blood vessels

- No history of non-healing wounds or ulcers within 28 days of registration

- No history of fracture within 28 days of registration

- No brain metastases or cranial epidural disease unless adequately treated,
stable, and off steroid support for at least 4 weeks prior to registration

- No known medical condition causing an inability to swallow oral formulations of
agents

- No history of allergic reaction attributed to compounds of similar chemical or
biological composition to cabozantinib/placebo

- No "currently active" second malignancy other than non-melanoma skin cancers or
cervical carcinoma in situ; patients are not considered to have a "currently
active" malignancy if they have completed therapy and are free of disease for >=
3 years

- Concomitant Medications

- Other planned concurrent investigational agents or other tumor directed therapies
(chemotherapy, radiation) are not allowed while on this study

- Concurrent use of somatostatin analogs while on cabozantinib/placebo is allowed
provided that the patient has been on a stable dose for at least two months

- Full dose oral anticoagulation/antiplatelet therapy is not permitted; low dose
aspirin =< 81 mg/day is allowed; anticoagulation with therapeutic doses of low
molecular weight heparin (LMWH) is allowed in patients who are on a stable dose
of LMWH for at least 6 weeks prior to registration; treatment with warfarin is
not allowed; anticoagulation in patients with brain metastases is not permitted

- Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed;
patients must discontinue the drug at least 14 days prior to registration on the
study

- Chronic concomitant treatment with strong CYP3A4 inducers is not allowed;
patients must discontinue the drug at least 14 days prior to the start of study
treatment

- Not pregnant and not nursing

- Women of childbearing potential must have a negative pregnancy test done =< 14
days prior to registration

- A female of childbearing potential is a sexually mature female who: 1) has not
undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal for at least 12 consecutive months (i.e. has had menses at any
time in the preceding 12 consecutive months)

- Eastern Cooperative Oncology Group (ECOG) performance status: 0-2

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Hemoglobin >= 9 g/dL

- Platelet count >= 100,000/mm^3

- Prothrombin time (PT)/ international normalized ratio (INR), partial thromboplastin
time (PTT) < 1.3 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 3 x ULN

- Total bilirubin =< 1.5 x ULN

- Except in the case of Gilbert disease, in which case total bilirubin must be =< 3
x ULN

- Creatinine =< 1.5 mg/dL OR creatinine clearance >= 45 mL/min

- Albumin >= 2.8 g/dL

- Potassium within normal limits (WNL)

- Phosphorus WNL

- Calcium WNL

- Magnesium WNL

- Urine protein to creatinine (UPC) ratio =< 1

- QT interval corrected for heart rate using Fridericia's formula (QTcF) =< 500 msec

- Thyroid-stimulating hormone (TSH) WNL

- Supplementation is acceptable to achieve a TSH WNL; in patients with abnormal
TSH, if free T4 is normal and patient is clinically euthyroid, patient is
eligible

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm I (cabozantinib S-malate)
Patients receive cabozantinib S-malate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Drug: Cabozantinib S-malate
    Given PO
    Other names:
    • BMS-907351
    • Cabometyx
    • Cometriq
    • XL184
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
Placebo Comparator
Arm II (placebo)
Patients receive placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Placebo
    Given PO
    Other names:
    • placebo therapy
    • PLCB
    • sham therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment

Recruiting Locations

Katmai Oncology Group
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

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

Kaiser Permanente-Deer Valley Medical Center
Antioch, California 94531
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Sutter Auburn Faith Hospital
Auburn, California 95602
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Mills-Peninsula Medical Center
Burlingame, California 94010
Contact:
Site Public Contact
650-696-4487
PazE@sutterhealth.org

Kaiser Permanente-Fremont
Fremont, California 94538
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Fremont
Fremont, California 94538
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Fresno
Fresno, California 93720
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Memorial Medical Center
Modesto, California 95355
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Modesto
Modesto, California 95356
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Camino Division
Mountain View, California 94040
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Oakland
Oakland, California 94611
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Richmond
Richmond, California 94801
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Roseville
Roseville, California 95661
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Sutter Roseville Medical Center
Roseville, California 95661
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente Downtown Commons
Sacramento, California 95814
Contact:
Site Public Contact
877-642-4691
kpoct@kp.org

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
916-454-6500
cancerinfo@sutterhealth.org

Kaiser Permanente-South Sacramento
Sacramento, California 95823
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-San Francisco
San Francisco, California 94115
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

UCSF Medical Center-Mission Bay
San Francisco, California 94158
Contact:
Site Public Contact
877-827-3222

Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente San Leandro
San Leandro, California 94577
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-San Rafael
San Rafael, California 94903
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser San Rafael-Gallinas
San Rafael, California 94903
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California 95065
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-South San Francisco
South San Francisco, California 94080
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Stockton
Stockton, California 95210
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente Medical Center-Vacaville
Vacaville, California 95688
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Vallejo
Vallejo, California 94589
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

National Jewish Health-Main Campus
Denver, Colorado 80206
Contact:
Site Public Contact
877-225-5654
glicht@co-cancerresearch.org

Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

SCL Health Saint Joseph Hospital
Denver, Colorado 80218
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Rocky Mountain Cancer Centers-Rose
Denver, Colorado 80220
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado 80113
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Swedish Medical Center
Englewood, Colorado 80113
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

National Jewish Health-Western Hematology Oncology
Golden, Colorado 80401
Contact:
Site Public Contact
303-777-2663
glicht@co-cancerresearch.org

Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado 81501
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

North Colorado Medical Center
Greeley, Colorado 80631
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Good Samaritan Medical Center
Lafayette, Colorado 80026
Contact:
Site Public Contact
303-673-1622

Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

McKee Medical Center
Loveland, Colorado 80539
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

National Jewish Health-Northern Hematology Oncology
Thornton, Colorado 80260
Contact:
Site Public Contact
303-777-2663
glicht@co-cancerresearch.org

SCL Health Lutheran Medical Center
Wheat Ridge, Colorado 80033
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

Moffitt Cancer Center
Tampa, Florida 33612
Contact:
Site Public Contact
800-679-0775
canceranswers@moffitt.org

Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-524-6115

Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii 96819
Contact:
Site Public Contact
808-432-5195
shelley.a.clark@kp.org

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

Saint Luke's Mountain States Tumor Institute
Boise, Idaho 83712
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

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

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

Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho 83619
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho 83686
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

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

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

Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho 83301
Contact:
Site Public Contact
773-702-9171
protocols@AllianceNCTN.org

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton, Illinois 61520
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Carthage
Carthage, Illinois 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

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

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4740
kcheek@dmhhs.org

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Illinois CancerCare-Eureka
Eureka, Illinois 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb, Illinois 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357

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

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

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Princeton
Princeton, Illinois 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

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

Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois 62226
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Memorial Hospital of South Bend
South Bend, Indiana 46601
Contact:
Site Public Contact
800-284-7370

Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Greater Regional Medical Center
Creston, Iowa 50801
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Iowa Methodist Medical Center
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727

Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-282-2921

Broadlawns Medical Center
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-282-2200

Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa 50314
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Trinity Regional Medical Center
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-574-8302

Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana 70805
Contact:
Site Public Contact
225-215-1353
clinicalresearch@marybird.com

Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana 70809
Contact:
Site Public Contact
225-215-1353
clinicalresearch@marybird.com

Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
Contact:
Site Public Contact
225-215-1353
clinicalresearch@marybird.com

Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana 70809
Contact:
Site Public Contact
225-757-0343
clinicalresearch@marybird.com

Northshore Oncology Associates-Covington
Covington, Louisiana 70433
Contact:
Site Public Contact
225-215-1353
clinicalresearch@marybird.com

Oncology Center of The South Incorporated
Houma, Louisiana 70360
Contact:
Site Public Contact
225-215-1353
clinicalresearch@marybird.com

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Site Public Contact
617-638-8265

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Site Public Contact
617-667-9925

Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Site Public Contact
877-442-3324

Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
Contact:
Site Public Contact
781-744-8027

Hickman Cancer Center
Adrian, Michigan 49221
Contact:
Site Public Contact
517-265-0116

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
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734-712-3671
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Genesee Hematology Oncology PC
Flint, Michigan 48503
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Genesys Hurley Cancer Institute
Flint, Michigan 48503
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734-712-3671
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Hurley Medical Center
Flint, Michigan 48503
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Hope Cancer Clinic
Livonia, Michigan 48154
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734-712-3671
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Saint Mary Mercy Hospital
Livonia, Michigan 48154
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734-712-3671
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Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
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Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
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IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
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734-712-3671
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Mercy Hospital
Coon Rapids, Minnesota 55433
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952-993-1517
mmcorc@healthpartners.com

Mayo Clinic
Rochester, Minnesota 55905
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855-776-0015

Regions Hospital
Saint Paul, Minnesota 55101
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952-993-1517
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Parkland Health Center-Bonne Terre
Bonne Terre, Missouri 63628
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314-996-5569

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
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573-334-2230
sfmc@sfmc.net

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
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800-600-3606
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Washington University School of Medicine
Saint Louis, Missouri 63110
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800-600-3606
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Siteman Cancer Center-South County
Saint Louis, Missouri 63129
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800-600-3606
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Missouri Baptist Medical Center
Saint Louis, Missouri 63131
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Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
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800-600-3606
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Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
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Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
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Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
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314-996-5569

Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
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314-996-5569

Community Hospital of Anaconda
Anaconda, Montana 59711
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406-969-6060
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Billings Clinic Cancer Center
Billings, Montana 59101
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800-996-2663
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Saint Vincent Frontier Cancer Center
Billings, Montana 59102
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800-648-6274

Bozeman Deaconess Hospital
Bozeman, Montana 59715
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406-969-6060
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Saint James Community Hospital and Cancer Treatment Center
Butte, Montana 59701
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406-723-2621

Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
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406-969-6060
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Kalispell Regional Medical Center
Kalispell, Montana 59901
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Community Medical Hospital
Missoula, Montana 59804
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CHI Health Saint Francis
Grand Island, Nebraska 68803
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308-398-6518
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Nebraska Methodist Hospital
Omaha, Nebraska 68114
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402-354-5144

OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
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702-384-0013
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OptumCare Cancer Care at Oakey
Las Vegas, Nevada 89106
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702-384-0013
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OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
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702-384-0013
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OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
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Renown Regional Medical Center
Reno, Nevada 89502
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University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
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505-925-0366
LByatt@nmcca.org

New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico 87109
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505-272-0530
CLee@nmcca.org

Hematology Oncology Associates of Central New York-Auburn
Auburn, New York 13021
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315-472-7504

Roswell Park Cancer Institute
Buffalo, New York 14263
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800-767-9355
askroswell@roswellpark.org

Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York 13057
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315-472-7504

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

Hematology Oncology Associates of Central New York-Onondaga Hill
Syracuse, New York 13215
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315-472-7504

Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
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919-587-9077
ecooke@cancersmoc.com

Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
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919-587-9077
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Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina 28791
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828-696-4716
karen.morris@unchealth.unc.edu

Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
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910-353-0824
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Strecker Cancer Center-Belpre
Belpre, Ohio 45714
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800-523-3977
sheree@columbusccop.org

Adena Regional Medical Center
Chillicothe, Ohio 45601
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877-779-7585
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
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800-293-5066
Jamesline@osumc.edu

Columbus Oncology and Hematology Associates Inc
Columbus, Ohio 43214
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614-488-2118
sheree@columbusccop.org

The Mark H Zangmeister Center
Columbus, Ohio 43219
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614-488-2118
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Doctors Hospital
Columbus, Ohio 43228
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614-566-3275
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Delaware Health Center-Grady Cancer Center
Delaware, Ohio 43015
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740-615-0227
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OhioHealth Mansfield Hospital
Mansfield, Ohio 44903
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419-526-8018
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Marietta Memorial Hospital
Marietta, Ohio 45750
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800-523-3977
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OhioHealth Marion General Hospital
Marion, Ohio 43302
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614-488-2118
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Licking Memorial Hospital
Newark, Ohio 43055
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740-348-4000
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Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio 43551
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419-479-5605
pshoup@toledoclinic.com

Southern Ohio Medical Center
Portsmouth, Ohio 45662
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614-488-2118
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Mercy Saint Anne Hospital
Toledo, Ohio 43623
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419-407-1160

Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio 43623
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800-444-3561

Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
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740-454-5232
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Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma 74146
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918-505-3200

Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
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Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
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Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
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Greenville Health System Cancer Institute-Easley
Easley, South Carolina 29640
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864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina 29605
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864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Faris
Greenville, South Carolina 29605
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864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina 29615
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864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Greer
Greer, South Carolina 29650
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864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina 29672
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864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina 29307
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864-241-6251
kwilliams8@ghs.org

ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
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research.institute@phci.org

ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
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262-928-7878

ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
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262-928-7632

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

More Details

NCT ID
NCT03375320
Status
Recruiting
Sponsor
National Cancer Institute (NCI)

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether cabozantinib S-malate (cabozantinib) can significantly improve progression-free survival (PFS) compared to placebo in patients with advanced pancreatic neuroendocrine tumors (NET) whose disease has progressed after treatment with everolimus.

II. To determine whether cabozantinib can significantly improve progression-free survival (PFS) compared to placebo in patients with advanced carcinoid tumors whose disease has progressed after treatment with everolimus.

SECONDARY OBJECTIVES:

I. To determine whether cabozantinib can significantly improve overall survival (OS) compared to placebo in patients with advanced pancreatic NET whose disease has progressed after treatment with everolimus.

II. To determine whether cabozantinib can significantly improve overall survival (OS) compared to placebo in patients with advanced carcinoid tumors whose disease has progressed after treatment with everolimus.

III. To evaluate safety and tolerability of cabozantinib versus placebo in patients with advanced pancreatic NET using Common Terminology Criteria for Adverse Events (CTCAE) and Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

IV. To evaluate safety and tolerability of cabozantinib versus placebo in patients with advanced carcinoid tumors using CTCAE and PRO-CTCAE.

V. To evaluate the overall radiographic response rate of cabozantinib versus placebo in patients with advanced pancreatic NET whose disease has progressed after treatment with everolimus.

VI. To evaluate the overall radiographic response rate of cabozantinib versus placebo in patients with advanced carcinoid tumors whose disease has progressed after treatment with everolimus.

OTHER OBJECTIVES:

I. Results of the primary analysis will be examined for consistency, while taking into account the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.

QUALITY OF LIFE SUBSTUDY OBJECTIVES:

I. To compare overall quality of life, disease-related symptoms, and other domains between the two treatment groups (cabozantinib versus [vs.] placebo) within each cohort of patients (pancreatic NET vs. carcinoid tumor). (Quality of Life Substudy Objective - A021602-HO1)

POPULATION PHARMACOKINETICS SUBSTUDY OBJECTIVES:

I. To describe the population pharmacokinetic and exposure-response relationships of cabozantinib in patients with advanced neuroendocrine tumors.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks until disease progression or start of new anticancer therapy, and then every 6 months until 8 years after registration.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.