Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer

January 28, 2021 updated by: National Cancer Institute (NCI)

Randomized Phase II Study Comparing Cabozantinib (NSC #761968) With Commercially Supplied Sunitinib in Patients With Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma

This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine if patients with renal cancer treated with cabozantinib (cabozantinib-s-malate) will have improved progression-free survival compared to patients treated with sunitinib (sunitinib malate).

SECONDARY OBJECTIVES:

I. To determine whether the response rate of patients with renal cancer treated with cabozantinib will be higher when compared with patients treated with sunitinib.

II. To determine whether patients with renal cancer treated with cabozantinib will have an improved overall survival when compared with patients treated with sunitinib.

TERTIARY OBJECTIVES:

I. To determine whether renal cancer patients with high MET expression by immunohistochemistry (IHC) have improvement in progression-free survival compared to patients with low MET expression on both arms of this study.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 5 years.

Study Type

Interventional

Enrollment (Actual)

157

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Mobile, Alabama, United States, 36608
    - Southern Cancer Center PC-Providence
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
- California
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Clovis, California, United States, 93611
    - Community Cancer Institute
  - Clovis, California, United States, 93611
    - University Oncology Associates
  - La Jolla, California, United States, 92093
    - UC San Diego Moores Cancer Center
  - San Diego, California, United States, 92161
    - San Diego VA Medical Center
  - San Francisco, California, United States, 94115
    - UCSF Medical Center-Mount Zion
- Colorado
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers-Aurora
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Boulder, Colorado, United States, 80304
    - Rocky Mountain Cancer Centers-Boulder
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, United States, 80218
    - SCL Health Saint Joseph Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers-Midtown
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers-Rose
  - Denver, Colorado, United States, 80218
    - Colorado Blood Cancer Institute
  - Denver, Colorado, United States, 80222
    - Western States Cancer Research NCORP
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Englewood, Colorado, United States, 80113
    - Mountain Blue Cancer Care Center - Swedish
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Golden, Colorado, United States, 80401
    - Mountain Blue Cancer Care Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Greenwood Village, Colorado, United States, 80111
    - Rocky Mountain Cancer Centers-Greenwood Village
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Littleton, Colorado, United States, 80120
    - Rocky Mountain Cancer Centers-Littleton
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers-Sky Ridge
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers-Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers - Pueblo
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers-Thornton
  - Wheat Ridge, Colorado, United States, 80033
    - SCL Health Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Smilow Cancer Hospital Care Center at Saint Francis
  - Middletown, Connecticut, United States, 06457
    - Middlesex Hospital
- Delaware
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Newark, Delaware, United States, 19713
    - Christiana Gynecologic Oncology LLC
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Seaford, Delaware, United States, 19973
    - TidalHealth Nanticoke / Allen Cancer Center
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - MedStar Washington Hospital Center
  - Washington, District of Columbia, United States, 20007
    - MedStar Georgetown University Hospital
- Florida
  - Jacksonville, Florida, United States, 32224-9980
    - Mayo Clinic in Florida
- Georgia
  - Savannah, Georgia, United States, 31404
    - Memorial Health University Medical Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - 'Aiea, Hawaii, United States, 96701
    - Queen's Cancer Center - Pearlridge
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Hawaii Cancer Care Inc - Waterfront Plaza
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Cancer Care Inc-Liliha
  - Honolulu, Hawaii, United States, 96817
    - Queen's Cancer Center - Kuakini
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Medical Center
  - Post Falls, Idaho, United States, 83854
    - Kootenai Cancer Center
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Cancer Clinic
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Bloomington, Illinois, United States, 61701
    - Saint Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60637
    - University of Chicago Comprehensive Cancer Center
  - Chicago, Illinois, United States, 60640
    - Weiss Memorial Hospital
  - Danville, Illinois, United States, 61832
    - Carle on Vermilion
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Decatur, Illinois, United States, 62526
    - Heartland Cancer Research NCORP
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, United States, 61401
    - Western Illinois Cancer Treatment Center
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Moline, Illinois, United States, 61265
    - Garneau, Stewart C MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Porubcin, Michael MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Spector, David MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Trinity Medical Center
  - Monmouth, Illinois, United States, 61462
    - Illinois CancerCare-Monmouth
  - Monmouth, Illinois, United States, 61462
    - Holy Family Medical Center
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center Foundation
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa, Illinois, United States, 61350
    - Radiation Oncology of Northern Illinois
  - Ottawa, Illinois, United States, 61350
    - Ottawa Regional Hospital and Healthcare Center
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Pekin, Illinois, United States, 61554
    - OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, United States, 61615
    - OSF Saint Francis Radiation Oncology at Peoria Cancer Center
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, United States, 61354
    - Valley Radiation Oncology
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - The Carle Foundation Hospital
  - Yorkville, Illinois, United States, 60560
    - Rush-Copley Healthcare Center
- Indiana
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology Oncology PC-Elkhart
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic
  - Fort Wayne, Indiana, United States, 46845
    - Fort Wayne Medical Oncology and Hematology Inc-Parkview
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - IU Health La Porte Hospital
  - Michigan City, Indiana, United States, 46360
    - Franciscan Saint Anthony Health-Michigan City
  - Michigan City, Indiana, United States, 46360
    - Woodland Cancer Care Center
  - Mishawaka, Indiana, United States, 46545
    - Memorial Regional Cancer Center Day Road
  - Mishawaka, Indiana, United States, 46545
    - Michiana Hematology Oncology PC-Mishawaka
  - Mishawaka, Indiana, United States, 46545
    - Saint Joseph Regional Medical Center-Mishawaka
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC-Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Health
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - Michiana Hematology Oncology PC-South Bend
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC-Westville
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC - Ames
  - Bettendorf, Iowa, United States, 52722
    - Constantinou, Costas L MD (UIA Investigator)
  - Bettendorf, Iowa, United States, 52722
    - University of Iowa Healthcare Cancer Services Quad Cities
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50309
    - Iowa-Wide Oncology Research Coalition NCORP
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates-Laurel
  - Iowa City, Iowa, United States, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
  - Iowa City, Iowa, United States, 52246
    - Iowa City VA Healthcare System
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center-Sioux City
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - West Des Moines, Iowa, United States, 50266-7700
    - Methodist West Hospital
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas-Liberal
  - Manhattan, Kansas, United States, 66502
    - Cancer Center of Kansas-Manhattan
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas - Newton
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, United States, 67214
    - Ascension Via Christi Hospitals Wichita
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Wichita, Kansas, United States, 67214
    - Wichita NCI Community Oncology Research Program
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Oncology Hematology Care Inc-Crestview
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
- Maine
  - Augusta, Maine, United States, 04330
    - Harold Alfond Center for Cancer Care
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
  - Rockport, Maine, United States, 04856
    - Penobscot Bay Medical Center
- Maryland
  - Baltimore, Maryland, United States, 21237
    - MedStar Franklin Square Medical Center/Weinberg Cancer Institute
  - Olney, Maryland, United States, 20832
    - MedStar Montgomery Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02115
    - Brigham and Women's Hospital
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital Cancer Center
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium NCORP
  - Dearborn, Michigan, United States, 48124
    - Beaumont Hospital - Dearborn
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48236
    - Ascension Saint John Hospital
  - Escanaba, Michigan, United States, 49829
    - Green Bay Oncology - Escanaba
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Iron Mountain, Michigan, United States, 49801
    - Green Bay Oncology - Iron Mountain
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49048
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital
  - Monroe, Michigan, United States, 48162
    - Toledo Clinic Cancer Centers-Monroe
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Lake Huron Medical Center
  - Saginaw, Michigan, United States, 48601
    - Ascension Saint Mary's Hospital
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Sanford Joe Lueken Cancer Center
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55454
    - Health Partners Inc
  - Minneapolis, Minnesota, United States, 55417
    - Minneapolis VA Medical Center
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic in Rochester
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center at Saint Cloud Hospital
  - Saint Cloud, Minnesota, United States, 56303
    - Saint Cloud Hospital
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro Minnesota Community Oncology Research Consortium
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
- Missouri
  - Bonne Terre, Missouri, United States, 63628
    - Parkland Health Center-Bonne Terre
  - Branson, Missouri, United States, 65616
    - Cox Cancer Center Branson
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Columbia, Missouri, United States, 65201
    - Veterans Administration
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Southwest Campus
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Rolla, Missouri, United States, 65401
    - Delbert Day Cancer Institute at PCRMC
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Springfield, Missouri, United States, 65804
    - Cancer Research for the Ozarks NCORP
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - Sullivan, Missouri, United States, 63080
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - Missouri Baptist Outpatient Center-Sunset Hills
- Montana
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59102
    - Montana Cancer Consortium NCORP
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59804
    - Community Medical Hospital
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists
- Nebraska
  - Lincoln, Nebraska, United States, 68506
    - Nebraska Hematology and Oncology
  - Lincoln, Nebraska, United States, 68510
    - Nebraska Cancer Research Center
  - Norfolk, Nebraska, United States, 68701
    - Faith Regional Health Services Carson Cancer Center
  - North Platte, Nebraska, United States, 69101
    - Great Plains Health Callahan Cancer Center
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68106
    - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68124
    - Nebraska Cancer Specialists - Omaha
  - Omaha, Nebraska, United States, 68130
    - Oncology Hematology West PC
  - Scottsbluff, Nebraska, United States, 69361
    - Regional West Medical Center Cancer Center
- Nevada
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, United States, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, United States, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, United States, 89074
    - 21st Century Oncology-Henderson
  - Las Vegas, Nevada, United States, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, United States, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89148
    - OptumCare Cancer Care at Fort Apache
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Cancer and Blood Specialists-Shadow
  - Las Vegas, Nevada, United States, 89109
    - HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  - Las Vegas, Nevada, United States, 89113
    - HealthCare Partners Medical Group Oncology/Hematology-San Martin
  - Las Vegas, Nevada, United States, 89121
    - Cancer Therapy and Integrative Medicine
  - Las Vegas, Nevada, United States, 89128
    - Cancer and Blood Specialists-Tenaya
  - Las Vegas, Nevada, United States, 89128
    - HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  - Las Vegas, Nevada, United States, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, United States, 89149
    - HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  - Las Vegas, Nevada, United States, 89169
    - Nevada Cancer Research Foundation NCORP
  - Las Vegas, Nevada, United States, 89109
    - 21st Century Oncology
  - Las Vegas, Nevada, United States, 89128
    - 21st Century Oncology-Vegas Tenaya
  - Las Vegas, Nevada, United States, 89148
    - 21st Century Oncology-Fort Apache
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology Hematology PA-Concord
  - Laconia, New Hampshire, United States, 03246
    - LRGHealthcare-Lakes Region General Hospital
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center
  - Manchester, New Hampshire, United States, 03103
    - Solinsky Center for Cancer Care
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Memorial Sloan Kettering Basking Ridge
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - Englewood, New Jersey, United States, 07631
    - Englewood Hospital and Medical Center
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - University of New Mexico Cancer Center
- New York
  - Auburn, New York, United States, 13021
    - Hematology Oncology Associates of Central New York-Auburn
  - Bronx, New York, United States, 10461
    - Montefiore Medical Center-Einstein Campus
  - Bronx, New York, United States, 10467
    - Montefiore Medical Center - Moses Campus
  - Bronx, New York, United States, 10461
    - Montefiore Medical Center-Weiler Hospital
  - Brooklyn, New York, United States, 11219
    - Maimonides Medical Center
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - Buffalo, New York, United States, 14215
    - Veterans Affairs Western New York Health Care System-Buffalo
  - Commack, New York, United States, 11725
    - Memorial Sloan Kettering Commack
  - East Syracuse, New York, United States, 13057
    - Hematology Oncology Associates of Central New York-East Syracuse
  - Glens Falls, New York, United States, 12801
    - Glens Falls Hospital
  - Lake Success, New York, United States, 11042
    - Northwell Health/Center for Advanced Medicine
  - Liverpool, New York, United States, 13088
    - Hematology Oncology Associates of Central New York-Liverpool
  - Manhasset, New York, United States, 11030
    - North Shore University Hospital
  - New Hyde Park, New York, United States, 11040
    - Long Island Jewish Medical Center
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, United States, 10032
    - NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  - New York, New York, United States, 10065
    - NYP/Weill Cornell Medical Center
  - Rome, New York, United States, 13440
    - Hematology Oncology Associates of Central New York-Rome
  - Sleepy Hollow, New York, United States, 10591
    - Memorial Sloan Kettering Sleepy Hollow
  - Syracuse, New York, United States, 13210
    - State University of New York Upstate Medical University
  - Syracuse, New York, United States, 13215
    - Hematology Oncology Associates of Central New York-Onondaga Hill
  - Uniondale, New York, United States, 11553
    - Memorial Sloan Kettering Nassau
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Novant Health Presbyterian Medical Center
  - Clinton, North Carolina, United States, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Goldsboro, North Carolina, United States, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Hendersonville, North Carolina, United States, 28791
    - Hendersonville Hematology and Oncology at Pardee
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Hendersonville, North Carolina, United States, 28792
    - AdventHealth Hendersonville
  - Jacksonville, North Carolina, United States, 28546
    - Southeastern Medical Oncology Center-Jacksonville
  - Kinston, North Carolina, United States, 28501
    - Vidant Oncology-Kinston
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth of the Carolinas-Moore Regional Hospital
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
  - Winston-Salem, North Carolina, United States, 27104
    - Southeast Clinical Oncology Research Consortium NCORP
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Clinic North-Fargo
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center
- Ohio
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Bowling Green, Ohio, United States, 43402
    - Toledo Clinic Cancer Centers-Bowling Green
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45242
    - Oncology Hematology Care Inc-Blue Ash
  - Cincinnati, Ohio, United States, 45202
    - Oncology Hematology Care Inc-Eden Park
  - Cincinnati, Ohio, United States, 45211
    - Oncology Hematology Care Inc-Mercy West
  - Cincinnati, Ohio, United States, 45230
    - Oncology Hematology Care Inc-Anderson
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc-Kenwood
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Columbus, Ohio, United States, 43215
    - Columbus NCI Community Oncology Research Program
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Miami Valley Hospital North
  - Dayton, Ohio, United States, 45459
    - Dayton NCI Community Oncology Research Program
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Delaware Radiation Oncology
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Fairfield, Ohio, United States, 45014
    - Oncology Hematology Care Inc-Healthplex
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lancaster, Ohio, United States, 43130
    - Lancaster Radiation Oncology
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Centers-Maumee
  - Maumee, Ohio, United States, 43537
    - Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Newark Radiation Oncology
  - Oregon, Ohio, United States, 43616
    - Saint Charles Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic Cancer Centers-Oregon
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Sylvania, Ohio, United States, 43560
    - ProMedica Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43606
    - ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
  - Toledo, Ohio, United States, 43608
    - Saint Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43623
    - Mercy Health - Saint Anne Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Centers-Toledo
  - Toledo, Ohio, United States, 43614
    - University of Toledo
  - Toledo, Ohio, United States, 43617
    - Toledo Community Hospital Oncology Program CCOP
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cancer Centers of Southwest Oklahoma Research
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Hospital Oklahoma City
  - Tulsa, Oklahoma, United States, 74146
    - Oklahoma Cancer Specialists and Research Institute-Tulsa
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at Saint Francis
  - Tulsa, Oklahoma, United States, 74146
    - Warren Clinic Oncology-Tulsa
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Medical Center-Cancer Center Hazleton
  - Pottsville, Pennsylvania, United States, 17901
    - Geisinger Cancer Services-Pottsville
  - Sayre, Pennsylvania, United States, 18840
    - Guthrie Medical Group PC-Robert Packer Hospital
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Boiling Springs, South Carolina, United States, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Easley, South Carolina, United States, 29640
    - Prisma Health Cancer Institute - Easley
  - Florence, South Carolina, United States, 29506
    - McLeod Regional Medical Center
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greenville, South Carolina, United States, 29601
    - Saint Francis Hospital
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Greenville Memorial Hospital
  - Greenville, South Carolina, United States, 29601
    - Greenville Health System Cancer Institute-Andrews
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Greer, South Carolina, United States, 29651
    - Gibbs Cancer Center-Pelham
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Medical Center
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Wellmont Medical Associates Oncology and Hematology-Bristol
  - Bristol, Tennessee, United States, 37620
    - Wellmont Bristol Regional Medical Center
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Holston Valley Hospital and Medical Center
  - Kingsport, Tennessee, United States, 37660
    - Regional Cancer Center at Indian Path Community Hospital
- Virginia
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology Inc
  - Norton, Virginia, United States, 24273
    - Southwest VA Regional Cancer Center
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University/Massey Cancer Center
- Washington
  - Longview, Washington, United States, 98632
    - PeaceHealth Saint John Medical Center
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
- Wisconsin
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, United States, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology Limited at Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Manitowoc, Wisconsin, United States, 54221
    - Holy Family Memorial Hospital
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - Mukwonago, Wisconsin, United States, 53149
    - ProHealth D N Greenwald Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oconomowoc, Wisconsin, United States, 53066
    - ProHealth Oconomowoc Memorial Hospital
  - Oconto Falls, Wisconsin, United States, 54154
    - Saint Vincent Hospital Cancer Center at Oconto Falls
  - Rhinelander, Wisconsin, United States, 54501
    - Ascension Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Sheboygan, Wisconsin, United States, 53081
    - HSHS Saint Nicholas Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Ascension Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology - Sturgeon Bay
  - Waukesha, Wisconsin, United States, 53188
    - ProHealth Waukesha Memorial Hospital
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic-Wausau Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Medical Center - Weston
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Cheyenne, Wyoming, United States, 82001
    - Cheyenne Regional Medical Center-West
  - Cody, Wyoming, United States, 82414
    - Big Horn Basin Cancer Center
  - Cody, Wyoming, United States, 82414
    - Billings Clinic-Cody
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (cabozantinib-s-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.	Other: Laboratory Biomarker Analysis Correlative studies Drug: Cabozantinib S-malate Given PO Other Names: BMS-907351 Cabometyx Cometriq XL-184 XL184
Active Comparator: Arm II (sunitinib malate) Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.	Other: Laboratory Biomarker Analysis Correlative studies Drug: Sunitinib Malate Given PO Other Names: Sutent SU011248 SU11248 sunitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) Time Frame: Up to 5 years	Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published	Up to 5 years
Overall Survival (OS) Time Frame: Up to 5 years	The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on OS. The Kaplan-Meier product-limit estimator will be used to estimate OS distributions.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rates Time Frame: Up to 5 years	Objective response rates (ORR) was investigator assessed. ORR is the rate of complete or partial responses, based on RECIST 1.1 criteria. A response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. The Fisher exact test will be used to compare the two treatment arms.	Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

Principal Investigator: Toni K Choueiri, Alliance for Clinical Trials in Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2013

Primary Completion (Actual)

April 18, 2016

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NCI-2013-00820 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA180821 (U.S. NIH Grant/Contract)
U10CA031946 (U.S. NIH Grant/Contract)
A031203 (Other Identifier: CTEP)

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Clinical Trials on Clear Cell Renal Cell Carcinoma

Jinling Hospital, China

Not yet recruiting

CD70-Targeted Immuno-PET/CT-Directed Free of Therapy Used for mccRCC Patients With IMDC Favorable or Intermediate Risk (PERFUMER-70)

Metastatic Clear Cell Renal Cell Carcinoma

China
NYU Langone Health
National Cancer Institute (NCI)

Recruiting

Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC)

Metastatic Clear Cell Renal Cell Carcinoma

United States
City of Hope Medical Center
National Cancer Institute (NCI)

Active, not recruiting

CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer

Metastatic Renal Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Advanced Renal Cell Carcinoma | Unresectable Renal Cell... and other conditions

United States
Sun Yat-sen University

Active, not recruiting

Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma

Non-Clear Cell Renal Cell Carcinoma

China
Arcus Biosciences, Inc.

Recruiting

Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Metastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma

United States, United Kingdom, Spain, Netherlands, France, Japan, Czechia, Poland, Italy, Germany, Romania, Australia, New Zealand, South Korea, Canada
Celldex Therapeutics

Terminated

A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and Ovarian Clear Cell Carcinoma

Kidney Neoplasms | Metastatic Renal Cell Carcinoma | Ovarian Clear Cell Carcinoma | Papillary Renal Cell Carcinoma | Renal Cell Carcinoma (RCC) | Clear-cell Renal Cell Carcinoma

United States
Neomorph, Inc

Recruiting

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma

Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | Kidney Cancer Metastatic | ccRCC | RCC | VHL-Associated Renal Cell Carcinoma | VHL-Associated Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma Metastatic | Kidney Cancers

United States
City of Hope Medical Center
National Cancer Institute (NCI)

Not yet recruiting

RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy

Metastatic Renal Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Advanced Renal Cell Carcinoma and other conditions

United States
City of Hope Medical Center
National Cancer Institute (NCI)

Recruiting

Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer

Metastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Advanced Sarcomatoid Renal Cell Carcinoma

United States
University of Michigan Rogel Cancer Center
United States Department of Defense

Recruiting

Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell Cancer, ICON Trial

Metastatic Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Locally Advanced Clear Cell Renal Cell Carcinoma | Locally Advanced Sarcomatoid Renal Cell Carcinoma

United States

Clinical Trials on Laboratory Biomarker Analysis

Children's Oncology Group
National Cancer Institute (NCI)

Completed

Biomarkers in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia

Leukemia
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)

Completed

DNA Changes in Patients With Prostate Cancer

Prostate Cancer
China National Center for Cardiovascular Diseases
Peking Union Medical College Hospital

Recruiting

Registration Study for Rare Type of Pulmonary Hypertension

Pulmonary Hypertension

China
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)

Completed

Gene Expression Profiles in Patients With Metastatic Pancreatic Cancer

Pancreatic Cancer

United States
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Active, not recruiting

Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia

Leukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic Leukemia

United States
Children's Oncology Group
National Cancer Institute (NCI)

Completed

Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Untreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic Leukemia

United States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
Children's Oncology Group
National Cancer Institute (NCI)

Completed

DNA Analysis of Tumor Tissue Samples From Young Patients With Acute Lymphoblastic Leukemia

Childhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic Leukemia

United States
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Completed

Studying Tumor Tissue Samples From Patients With Early-Stage Non-Small Cell Lung Cancer

Lung Cancer

United States
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Completed

Studying Biomarkers in Tumor Tissue and Blood Samples From Patients With Small Cell Lung Cancer Registered on CALGB-140202

Lung Cancer

United States
Children's Oncology Group
National Cancer Institute (NCI)

Withdrawn

Studying Biomarkers in Samples From Younger Patients With Kidney Cancer

Clear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney Neoplasm

United States

Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer

Randomized Phase II Study Comparing Cabozantinib (NSC #761968) With Commercially Supplied Sunitinib in Patients With Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma

Study Overview

Status

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Intervention / Treatment

Detailed Description

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Enrollment (Actual)

Phase

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Ages Eligible for Study

Accepts Healthy Volunteers

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Description

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What is the study measuring?

Primary Outcome Measures

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Last Update Submitted That Met QC Criteria

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Clinical Trials on Clear Cell Renal Cell Carcinoma

Clinical Trials on Laboratory Biomarker Analysis

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