Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Atypical Carcinoid Tumor, Carcinoid Tumor, Functioning Pancreatic Neuroendocrine Tumor
About this trial
This is an interventional treatment trial for Atypical Carcinoid Tumor
Eligibility 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, thymus, other, or unknown primary site; GI, lung, thymus, other, 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 experienced disease progression on or intolerance leading to treatment discontinuation of at least one Food and Drug Administration (FDA)-approved line of therapy (except somatostatin analogs); prior lines of therapy may include: everolimus, sunitinib, or lutetium Lu 177 dotatate in patients with pancreatic NET; everolimus in patients with lung NET; everolimus or lutetium Lu 177 dotatate in patients with gastrointestinal NET
- 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 with invasion into the GI tract from the outside causing increased risk of perforation or bleeding 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)
- Age >= 18 years
- 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)
- Supplementation is acceptable to achieve a value WNL; in patients with low albumin levels, a corrected calcium value WNL is acceptable; in patients with abnormal thyroid stimulating hormone (TSH), if free T4 is normal and patient is clinically euthyroid, patient is eligible
Phosphorus WNL
- Supplementation is acceptable to achieve a value WNL; in patients with low albumin levels, a corrected calcium value WNL is acceptable; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
Calcium WNL Phosphorus WNL
- Supplementation is acceptable to achieve a value WNL; in patients with low albumin levels, a corrected calcium value WNL is acceptable; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
Magnesium WNL
- Supplementation is acceptable to achieve a value WNL; in patients with low albumin levels, a corrected calcium value WNL is acceptable; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
- Urine protein to creatinine (UPC) ratio =< 1
- QT interval corrected for heart rate using Fridericia's formula (QTcF) =< 500 msec
TSH WNL
- Supplementation is acceptable to achieve a value WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
Sites / Locations
- Katmai Oncology Group
- Kingman Regional Medical Center
- Mayo Clinic Hospital in Arizona
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- University of Arkansas for Medical Sciences
- Kaiser Permanente-Deer Valley Medical Center
- PCR Oncology
- Sutter Auburn Faith Hospital
- Alta Bates Summit Medical Center-Herrick Campus
- Mills-Peninsula Medical Center
- City of Hope Comprehensive Cancer Center
- Epic Care-Dublin
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fremont
- Palo Alto Medical Foundation-Fremont
- Kaiser Permanente-Fresno
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- Palo Alto Medical Foundation-Camino Division
- Alta Bates Summit Medical Center - Summit Campus
- Kaiser Permanente-Oakland
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute Palo Alto
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- Sutter Roseville Medical Center
- Kaiser Permanente Downtown Commons
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- Salinas Valley Memorial
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- UCSF Medical Center-Mission Bay
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Mills Health Center
- Kaiser Permanente-San Rafael
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Rocky Mountain Cancer Centers-Aurora
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- National Jewish Health-Main Campus
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- National Jewish Health-Western Hematology Oncology
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Good Samaritan Medical Center
- Rocky Mountain Cancer Centers-Littleton
- Rocky Mountain Cancer Centers-Sky Ridge
- McKee Medical Center
- National Jewish Health-Northern Hematology Oncology
- SCL Health Lutheran Medical Center
- Danbury Hospital
- Norwalk Hospital
- MedStar Georgetown University Hospital
- GenesisCare USA - Aventura FP
- GenesisCare USA - Aventura
- GenesisCare USA - Boca Ration FP06
- Regional Cancer Center-Lee Memorial Health System
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Mayo Clinic in Florida
- Moffitt Cancer Center
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Hawaii Cancer Care - Westridge
- Pali Momi Medical Center
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- Queen's Cancer Center - Kuakini
- Kaiser Permanente Moanalua Medical Center
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Alphonsus Cancer Care Center-Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- University of Illinois
- University of Chicago Comprehensive Cancer Center
- Carle at The Riverfront
- Cancer Care Specialists of Illinois - Decatur
- Illinois CancerCare-Dixon
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- UC Comprehensive Cancer Center at Silver Cross
- Cancer Care Center of O'Fallon
- University of Chicago Medicine-Orland Park
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Illinois CancerCare-Peru
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Carle Cancer Center
- Illinois CancerCare - Washington
- Memorial Hospital of South Bend
- University of Iowa Healthcare Cancer Services Quad Cities
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Jennie Edmundson Memorial Hospital
- Heartland Oncology and Hematology LLP
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Trinity Regional Medical Center
- University of Iowa/Holden Comprehensive Cancer Center
- Mercy Medical Center-West Lakes
- University of Kentucky/Markey Cancer Center
- LSU Health Baton Rouge-North Clinic
- Our Lady of The Lake
- Louisiana Hematology Oncology Associates LLC
- Mary Bird Perkins Cancer Center
- Our Lady of the Lake Physicians Group - Medical Oncology
- Northshore Oncology Associates-Covington
- Oncology Center of The South Incorporated
- Brigham and Women's Hospital
- Boston Medical Center
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Lahey Hospital and Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- Saint Joseph Mercy Brighton
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
- Saint Joseph Mercy Canton
- Trinity Health IHA Medical Group Hematology Oncology - Canton
- Caro Cancer Center
- Saint Joseph Mercy Chelsea
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
- Hematology Oncology Consultants-Clarkston
- McLaren Cancer Institute-Clarkston
- Newland Medical Associates-Clarkston
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Weisberg Cancer Treatment Center
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- McLaren Cancer Institute-Flint
- Singh and Arora Hematology Oncology PC
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Ascension Borgess Cancer Center
- Karmanos Cancer Institute at McLaren Greater Lansing
- Sparrow Hospital
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Toledo Clinic Cancer Centers-Monroe
- McLaren Cancer Institute-Macomb
- McLaren Cancer Institute-Central Michigan
- McLaren Cancer Institute-Northern Michigan
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Huron Medical Center PC
- Lake Huron Medical Center
- McLaren-Port Huron
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph Hospital
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- Huron Gastroenterology PC
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
- Sanford Joe Lueken Cancer Center
- Fairview Ridges Hospital
- Minnesota Oncology - Burnsville
- Mercy Hospital
- Essentia Health - Deer River Clinic
- Essentia Health Cancer Center
- Fairview Southdale Hospital
- Unity Hospital
- Essentia Health Hibbing Clinic
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Essentia Health Sandstone
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Fairview Lakes Medical Center
- Parkland Health Center-Bonne Terre
- Saint Francis Medical Center
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - Farmington
- Washington University School of Medicine
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Community Medical Hospital
- CHI Health Saint Francis
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
- Nebraska Methodist Hospital
- Oncology Associates PC
- Carson Tahoe Regional Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven Hills
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- GenesisCare USA - Henderson
- Desert West Surgery
- OptumCare Cancer Care at Charleston
- University Medical Center of Southern Nevada
- Hope Cancer Care of Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- GenesisCare USA - Las Vegas
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- Ann M Wierman MD LTD
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- GenesisCare USA - Vegas Tenaya
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- OptumCare Cancer Care at MountainView
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- Comprehensive Cancer Centers of Nevada
- GenesisCare USA - Fort Apache
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- University Cancer Center
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Dartmouth Cancer Center - Nashua
- Memorial Sloan Kettering Basking Ridge
- Englewood Hospital and Medical Center
- Memorial Sloan Kettering Monmouth
- Memorial Sloan Kettering Bergen
- The Valley Hospital-Luckow Pavilion
- Valley Hospital
- Valley Medical Group - Wayne Multispecialty Practice
- University of New Mexico Cancer Center
- New Mexico Oncology Hematology Consultants
- Presbyterian Kaseman Hospital
- Presbyterian Rust Medical Center/Jorgensen Cancer Center
- Hematology Oncology Associates of Central New York-Auburn
- Roswell Park Cancer Institute
- Memorial Sloan Kettering Commack
- Hematology Oncology Associates of Central New York-East Syracuse
- Memorial Sloan Kettering Westchester
- Mount Sinai Hospital
- Memorial Sloan Kettering Cancer Center
- University of Rochester
- Hematology Oncology Associates of Central New York-Onondaga Hill
- Memorial Sloan Kettering Nassau
- Wilmot Cancer Institute at Webster
- UNC Lineberger Comprehensive Cancer Center
- Southeastern Medical Oncology Center-Clinton
- Southeastern Medical Oncology Center-Goldsboro
- Margaret R Pardee Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kinston
- Marion L Shepard Cancer Center at Vidant Beaufort Hospital
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- UHHS-Chagrin Highlands Medical Center
- Strecker Cancer Center-Belpre
- Miami Valley Hospital South
- Adena Regional Medical Center
- Case Western Reserve University
- Ohio State University Comprehensive Cancer Center
- Columbus Oncology and Hematology Associates Inc
- Grant Medical Center
- The Mark H Zangmeister Center
- Doctors Hospital
- Dayton Blood and Cancer Center
- Miami Valley Hospital
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer Center
- Atrium Medical Center-Middletown Regional Hospital
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- Licking Memorial Hospital
- University Hospitals Parma Medical Center
- Mercy Health Perrysburg Cancer Center
- Southern Ohio Medical Center
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- University Hospitals Sharon Health Center
- UH Seidman Cancer Center at Saint John Medical Center
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Alphonsus Medical Center-Baker City
- Providence Cancer Institute Clackamas Clinic
- Legacy Mount Hood Medical Center
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Legacy Meridian Park Hospital
- Lehigh Valley Hospital-Cedar Crest
- Lehigh Valley Hospital - Muhlenberg
- Pocono Medical Center
- Saint Vincent Hospital
- Lehigh Valley Hospital-Hazleton
- Jefferson Hospital
- Forbes Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- Allegheny General Hospital
- West Penn Hospital
- Wexford Health and Wellness Pavilion
- Prisma Health Cancer Institute - Spartanburg
- Prisma Health Cancer Institute - Easley
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- Farmington Health Center
- University of Utah Sugarhouse Health Center
- Huntsman Cancer Institute/University of Utah
- Virginia Mason Medical Center
- Legacy Salmon Creek Hospital
- Edwards Comprehensive Cancer Center
- West Virginia University Healthcare
- ThedaCare Regional Cancer Center
- Duluth Clinic Ashland
- Marshfield Medical Center-EC Cancer Center
- University of Wisconsin Carbone Cancer Center
- Marshfield Medical Center-Marshfield
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Marshfield Medical Center-Rice Lake
- Marshfield Medical Center-River Region at Stevens Point
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- Marshfield Medical Center - Weston
- Billings Clinic-Cody
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I (cabozantinib S-malate)
Arm II (placebo)
Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study.
Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression.