Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Metastatic Kidney Carcinoma, Stage III Renal Cell Cancer AJCC v7
About this trial
This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Renal cell carcinoma with some component of clear cell histology; histologic documentation of metastatic disease is not required
- Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma (RCC) (equivalent to stage IV RCC, according to American Joint Committee on Cancer [AJCC] staging)
Eligible patients must be intermediate/poor risk, per the International Metastatic Renal Cell Carcinoma (mRCC) Database Consortium (Heng) criteria; patients must therefore have as one or more of the following six factors:
Time from diagnosis of RCC to systemic treatment < 1 year
- Note: systemic treatment refers to the initiation of A031203 protocol treatment
- Hemoglobin < the lower limit of normal (LLN)
- Corrected calcium > the upper limit of normal (ULN)
- Karnofsky performance status < 80%
- Neutrophil count > ULN
- Platelet count > ULN
- No radiographic evidence of cavitating pulmonary lesion(s)
- No tumor invading the inferior vena cava (IVC) or superior vena cava (SVC) blood vessels
- No evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days prior to registration
- No prior systemic treatment for RCC; supportive therapies such as bisphosphonates (zoledronic acid) or denosumab are permitted
- Patients must not have had a major surgical procedure or significant traumatic injury within 6 weeks prior to study registration, and must have fully recovered from any such procedure; however, patients who have had a nephrectomy may be enrolled 4 weeks after surgery, providing there are no wound-healing complications; the following are not considered to be major procedures: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and routine dental procedures
Radiation:
- To the brain, thoracic cavity, abdomen, or pelvis must be completed at least 90 days before registration;
- To bone must be completed at least 14 days before registration; and
- To any other sites must be completed at least 28 days before registration In all cases, there must be complete recovery and no ongoing complications from prior radiation therapy
- No chronic concomitant treatment of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors; patients may not have received a strong CYP3A4 inducer within 12 days prior to registration nor a strong CYP3A4 inhibitor within 7 days prior to registration
- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria; lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan
No active brain metastases; patients with treated, stable brain metastases for at least three months are eligible as long as they meet the following criteria:
- Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 3 months, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or CT); (stable dose of anticonvulsants are allowed); treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator [LINAC], or equivalent) or a combination as deemed appropriate by the treating physician; patients with central nervous system (CNS) metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to registration are not eligible
- Baseline brain imaging (MRI/CT) is required
- No serious non-healing wound, ulcer, or bone fracture requiring intervention within 28 days prior to registration
- No arterial thrombotic events within 6 months prior to registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medical intervention in the 6 months prior to registration, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block), significant vascular disease (i.e., aortic aneurysm, history of aortic dissection), or any other arterial thrombotic event are ineligible
- No history of pulmonary embolism or untreated deep venous thrombosis (DVT) within 6 months prior to registration; note: patients with recent DVT who have been treated with therapeutic anticoagulation with low molecular weight heparin for at least 6 weeks are eligible; patients receiving therapeutic warfarin (> 2 mg/day) are not eligible; patients on warfarin may be switched to low molecular weight heparin at the discretion of the treating physician
- No inadequately controlled hypertension (defined as a blood pressure of >= 150 mmHg systolic and/or >= 90 mmHg diastolic), or any prior history of hypertensive crisis or hypertensive encephalopathy
- No New York Heart Association (NYHA) class >= 2 congestive heart failure
- Ejection fraction on echocardiogram (Echo) or multi gated acquisition scan (MUGA) > 50%
- No corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
- No history of congenital QT syndrome
- No unstable cardiac arrhythmia within 6 months prior to registration
No evidence of any of the following:
- Clinically-significant gastrointestinal bleeding within 6 months before registration; or
- Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months before registration; or
- Any other signs indicative of pulmonary hemorrhage within 3 months before registration
- No history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 6 months prior to registration and complete healing/resolution prior to registration; no percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months prior to registration
- No active peptic ulcer disease, within 28 days before registration
- No inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis within 28 days before registration
- No malabsorption syndrome within 28 days before registration
- No uncompensated hypothyroidism; patients with hypothyroidism on therapy are required to have thyroid stimulating hormone (TSH) within normal limits
- No radiologic or clinical evidence of pancreatitis
- No history of organ transplant
- Patients with active infection requiring systemic treatment within 28 days prior to registration are not eligible
Patients who are pregnant or nursing are not eligible; women of child bearing potential must have a negative serum or urine pregnancy test within 16 days prior to registration; women of child-bearing potential include:
- Any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months)
- Women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35m IU/mL
- Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy)
- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
- Archival tissue must be available for submission, though it is optional for patients to choose to participate in the correlative sub studies
- Absolute neutrophil count (ANC) >= 1,500/uL
- Platelet count >= 100,000/uL
- Hemoglobin >= 9 g/dL; patients may not have had a transfusion within 7 days prior to screening assessment
- Total bilirubin =< 1.5 x upper limits of normal
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN
- Albumin >= 2.8 g/dL
- Serum creatinine =< 1.5 x ULN, OR calculated creatinine clearance >= 30 mL/minute (modified Cockcroft and Gault formula)
- Urine protein to creatinine (UPC) ratio < 1.0; if UPC >= 1, then a 24-hour urine protein must be assessed; eligible patients must have a 24-hour urine protein value < 1 g
- Total serum calcium < 12 mg/dL
- International normalized ratio (INR) =< 1.2 x ULN; subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation
- TSH within normal limits (WNL); TSH only required for patients on thyroid supplementation
Sites / Locations
- Southern Cancer Center PC-Providence
- Alaska Breast Care and Surgery LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Community Cancer Institute
- University Oncology Associates
- UC San Diego Moores Cancer Center
- San Diego VA Medical Center
- UCSF Medical Center-Mount Zion
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Western States Cancer Research NCORP
- Mercy Medical Center
- Mountain Blue Cancer Care Center - Swedish
- Swedish Medical Center
- Mountain Blue Cancer Care Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital Care Center at Saint Francis
- Middlesex Hospital
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Christiana Care Health System-Wilmington Hospital
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- Mayo Clinic in Florida
- Memorial Health University Medical Center
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Queen's Cancer Center - Kuakini
- Castle Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Kootenai Medical Center
- Kootenai Cancer Center
- Kootenai Cancer Clinic
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- University of Chicago Comprehensive Cancer Center
- Weiss Memorial Hospital
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- Community Cancer Center Foundation
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Proctor Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Community Howard Regional Health
- IU Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- McFarland Clinic PC - Ames
- Constantinou, Costas L MD (UIA Investigator)
- 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
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- Iowa City VA Healthcare System
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Oncology Hematology Care Inc-Crestview
- University of Kentucky/Markey Cancer Center
- Ochsner Medical Center Jefferson
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Penobscot Bay Medical Center
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- MedStar Montgomery Medical Center
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Boston Medical Center
- Dana-Farber Cancer Institute
- Bixby Medical Center
- Hickman Cancer Center
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- Beaumont Hospital - Dearborn
- Henry Ford Hospital
- Ascension Saint John Hospital
- Green Bay Oncology - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Ascension Saint Mary's Hospital
- Saint John Macomb-Oakland Hospital
- Sanford Joe Lueken Cancer Center
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Minneapolis VA Medical Center
- Health Partners Inc
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Veterans Administration
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Mercy Hospital Saint Louis
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Nebraska Hematology and Oncology
- Nebraska Cancer Research Center
- Faith Regional Health Services Carson Cancer Center
- Great Plains Health Callahan Cancer Center
- Missouri Valley Cancer Consortium
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Nebraska Cancer Specialists - Omaha
- Alegent Health Lakeside Hospital
- Oncology Hematology West PC
- Creighton University Medical Center
- Regional West Medical Center Cancer Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- 21st Century Oncology-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- 21st Century Oncology
- 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
- 21st Century Oncology-Vegas Tenaya
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Comprehensive Cancer Centers of Nevada-Summerlin
- Las Vegas Cancer Center-Medical Center
- 21st Century Oncology-Fort Apache
- Comprehensive Cancer Centers of Nevada
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- Nevada Cancer Research Foundation NCORP
- New Hampshire Oncology Hematology PA-Concord
- LRGHealthcare-Lakes Region General Hospital
- Dartmouth Hitchcock Medical Center
- Solinsky Center for Cancer Care
- Memorial Sloan Kettering Basking Ridge
- Cooper Hospital University Medical Center
- Englewood Hospital and Medical Center
- Hackensack University Medical Center
- University of New Mexico Cancer Center
- Hematology Oncology Associates of Central New York-Auburn
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Maimonides Medical Center
- Veterans Affairs Western New York Health Care System-Buffalo
- Roswell Park Cancer Institute
- Memorial Sloan Kettering Commack
- Hematology Oncology Associates of Central New York-East Syracuse
- Glens Falls Hospital
- Northwell Health/Center for Advanced Medicine
- Hematology Oncology Associates of Central New York-Liverpool
- North Shore University Hospital
- Long Island Jewish Medical Center
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer Center
- NYP/Weill Cornell Medical Center
- Hematology Oncology Associates of Central New York-Rome
- Memorial Sloan Kettering Sleepy Hollow
- State University of New York Upstate Medical University
- Hematology Oncology Associates of Central New York-Onondaga Hill
- Memorial Sloan Kettering Nassau
- Novant Health Presbyterian Medical Center
- Southeastern Medical Oncology Center-Clinton
- Duke University Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- AdventHealth Hendersonville
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kinston
- FirstHealth of the Carolinas-Moore Regional Hospital
- Iredell Memorial Hospital
- Southeast Clinical Oncology Research Consortium NCORP
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Sanford Roger Maris Cancer Center
- Altru Cancer Center
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- Oncology Hematology Care Inc-Anderson
- Oncology Hematology Care Inc-Kenwood
- Oncology Hematology Care Inc-Blue Ash
- Ohio State University Comprehensive Cancer Center
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Dayton NCI Community Oncology Research Program
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Oncology Hematology Care Inc-Healthplex
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Lima Memorial Hospital
- Marietta Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Southern Ohio Medical Center
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- Mercy Hospital of Tiffin
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- Saint Ann's Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Natalie Warren Bryant Cancer Center at Saint Francis
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Warren Clinic Oncology-Tulsa
- Clackamas Radiation Oncology Center
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- Geisinger Cancer Services-Pottsville
- Guthrie Medical Group PC-Robert Packer Hospital
- Geisinger Medical Group
- Geisinger Wyoming Valley/Henry Cancer Center
- AnMed Health Cancer Center
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Easley
- McLeod Regional Medical Center
- Greenville Health System Cancer Institute-Andrews
- Saint Francis Hospital
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Gibbs Cancer Center-Pelham
- Prisma Health Cancer Institute - Seneca
- Spartanburg Medical Center
- Rapid City Regional Hospital
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Wellmont Bristol Regional Medical Center
- Wellmont Medical Associates Oncology and Hematology-Bristol
- Regional Cancer Center at Indian Path Community Hospital
- Wellmont Holston Valley Hospital and Medical Center
- Fredericksburg Oncology Inc
- Southwest VA Regional Cancer Center
- Virginia Commonwealth University/Massey Cancer Center
- PeaceHealth Saint John Medical Center
- PeaceHealth Southwest Medical Center
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Gundersen Lutheran Medical Center
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Ascension Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- HSHS Saint Nicholas Hospital
- Ascension Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- ProHealth Waukesha Memorial Hospital
- Marshfield Clinic-Wausau Center
- Marshfield Medical Center - Weston
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Cheyenne Regional Medical Center-West
- Big Horn Basin Cancer Center
- Billings Clinic-Cody
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm I (cabozantinib-s-malate)
Arm II (sunitinib malate)
Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.