Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed
Locally Advanced Papillary Renal Cell Carcinoma, Metastatic Papillary Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v7
About this trial
This is an interventional treatment trial for Locally Advanced Papillary Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection; (NOTE: a designation of type I or type II should be made by the local pathologist if possible); mixed histologies containing type I or type II will be allowed provided that they contain >= 50% of the papillary component
- Patients must also have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension; disease X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; if there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan should be performed at baseline (within 42 days prior to registration); all disease must be assessed and documented on the Baseline Tumor Assessment form
- Patients with a history of treated brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible; anti-seizure medications are allowed provided they are non-enzyme inducing (e.g. topiramate, levetiracetam, gabapentin)
- Patients must not have cavitating pulmonary lesions; patients must not have tumor invading the gastrointestinal (GI) tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration
- Patients may have received prior surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
- Patients may have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor Food and Drug Administration (FDA)-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib); if a patient develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic renal cell carcinoma (RCC); if a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC; patients may have also received prior immunotherapy; patients must not have received a MET/hepatocyte growth factor (HGF) inhibitor or sunitinib as prior therapy; at least 14 days must have elapsed since completion of prior systemic therapy; patients must have recovered from all associated toxicities at the time of registration
- Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 14 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration
- Patients must not be taking, nor plan to take while on protocol treatment, strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipravavir/RIT, or voriconazole); strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); potent inhibitors of CYP1A2 (e.g. ciprofloxacin); and/or drugs known to be CYP3A4 substrates with a narrow therapeutic range (e.g., diergotamine, ergotamine) within 14 days prior to randomization; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution
- Patients must not be receiving or planning to receive any other investigational agents
- Patients must have a complete physical examination and medical history within 28 days prior to registration
- Patients must have a Zubrod performance status of 0 - 1
- White blood cell count (WBC) >= 2,000/mcL (must be obtained within 28 days prior to registration)
- Absolute neutrophil count (ANC) >= 1,000/mcL (must be obtained within 28 days prior to registration)
- Platelet count >= 75,000/mcL (must be obtained within 28 days prior to registration)
- Serum bilirubin =< 1.5 x institutional upper limits of normal (ULN) (must be obtained within 28 days prior to registration)
- Serum transaminase (serum glutamic oxaloacetic transaminase [SGOT]/aspartate aminotransferase [AST] and serum glutamate pyruvate transaminase [SGPT]/alanine aminotransferase [ALT]) must be =< 2.5 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGOT/SGPT) must be =< 5 x the institutional ULN (must be obtained within 28 days prior to registration)
- Serum creatinine must be =< 2 x the institutional ULN OR creatinine clearance (either measured or calculated) must be > 30 mL/min (must be obtained within 28 days prior to registration)
- Patients must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association [NYHA] class III [moderate] or class IV [severe]) at the time of registration; baseline echocardiogram within 28 days of registration must demonstrate an ejection fraction (EF) >= 50%; due to the potential cardiac toxicity of the agents utilized in this protocol, patients must have corrected QT (QTc) interval < 500 msec on prestudy electrocardiogram (EKG) and no known history of congenital long QT syndrome; patients must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack [TIA] or other ischemic event) within 3 months prior to registration and not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 6 months of registration; prestudy EKG must be obtained within 28 days prior to registration
- Baseline urinalysis should show urine protein < 3+ and must be obtained within 28 days prior to registration; if urine protein is 3+ or greater, then urine protein by 24 hour collection must show less than 3 grams of protein
- Patients must not have inadequately controlled hypertension; patients must have documented blood pressures of systolic blood pressure (SBP) < 150 and diastolic blood pressure (DBP) < 90 within 14 days of starting randomization; blood pressure medications (any number) are permitted
- Patients must be able to take oral medications (i.e., swallow pills whole); patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures that could in the opinion of the treating investigator affect absorption, or active peptic ulcer disease; patients with intractable nausea or vomiting are not eligible
- Patients must not have had any clinically-significant GI bleeding within 6 months prior to registration and patients must not have a GI disorder which (at the discretion of the investigator) bears a high risk of perforation or fistula; examples of this include (but are not limited to) Crohn's disease or tumor with transmural extension through the gastrointestinal lining
- Patients must not have had hemoptysis of >= 0.5 teaspoon (2.5 ml) of red blood within 3 months prior registration
- Patients must not demonstrate any other signs indicative of pulmonary hemorrhage within 3 months prior to registration
- Patient's baseline imaging must not indicate the presence of tumor invading or encasing any major blood vessels
- Patients must not have any unresolved wounds from previous surgery
- Albumin, alkaline phosphatase, bicarbonate, blood urea (BUN), chloride, glucose, phosphorus, and total protein must be assessed within 28 days of registration
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 3 years; men receiving active surveillance for prostate cancer may also be enrolled
- Due to the unknown effects of the study drugs, patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for three months after last dose of study drug; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cabozantinib, crizotinib, savolitinib or sunitinib; in addition these patients are at increased risk of lethal infections when treated with marrow suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
- Patients must have tissue available and be willing to submit for independent pathologic review in order to classify type I versus type II papillary disease
- Patients must be offered the opportunity to participate in specimen banking for future translational medicine studies
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Kingman Regional Medical Center
- Mercy Hospital Fort Smith
- John L McClellan Memorial Veterans Hospital
- PCR Oncology
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- AIS Cancer Center at San Joaquin Community Hospital
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Eden Hospital Medical Center
- Sutter Davis Hospital
- City of Hope Comprehensive Cancer Center
- Epic Care-Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Palo Alto Medical Foundation-Fremont
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Cedars Sinai Medical Center
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Memorial Medical Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- USC Norris Oncology/Hematology-Newport Beach
- Sutter Cancer Research Consortium
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Palo Alto Medical Foundation Health Care
- Keck Medical Center of USC Pasadena
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- California Pacific Medical Center-Pacific Campus
- Palo Alto Medical Foundation-Santa Cruz
- Sutter Pacific Medical Foundation
- Palo Alto Medical Foundation-Sunnyvale
- Gene Upshaw Memorial Tahoe Forest Cancer Center
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Sutter Solano Medical Center/Cancer Center
- Epic Care Cyberknife Center
- Grand Valley Oncology
- Smilow Cancer Hospital Care Center at Saint Francis
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- Sibley Memorial Hospital
- Mount Sinai Comprehensive Cancer Center at Aventura
- Holy Cross Hospital
- Mount Sinai Medical Center
- Low Country Cancer Care
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Summit Cancer Care-Candler
- Hawaii Cancer Care - Savio
- Pali Momi Medical Center
- Queen's Cancer Center - Pearlridge
- The Cancer Center of Hawaii-Pali Momi
- Hawaii Cancer Care Inc - Waterfront Plaza
- Island Urology
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Hawaii Cancer Care Inc-Liliha
- Kuakini Medical Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Health - Coeur d'Alene
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Alphonsus Medical Center-Nampa
- Saint Luke's Cancer Institute - Nampa
- Kootenai Clinic Cancer Services - Post Falls
- Kootenai Cancer Clinic
- Saint Luke's Cancer Institute - Twin Falls
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- University of Chicago Comprehensive Cancer Center
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Illinois CancerCare-Dixon
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Illinois CancerCare-Kewanee Clinic
- Northwestern Medicine Lake Forest Hospital
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- 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
- SwedishAmerican Regional Cancer Center/ACT
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Rush-Copley Healthcare Center
- Deaconess Clinic Downtown
- Indiana University/Melvin and Bren Simon Cancer Center
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Chancellor Center for Oncology
- Reid Health
- Memorial Hospital of South Bend
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Iowa Lutheran Hospital
- Trinity Regional Medical Center
- Methodist West Hospital
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cotton O'Neil Cancer Center / Stormont Vail Health
- 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
- Cancer Center of Kansas - Winfield
- Oncology Hematology Care Inc-Crestview
- East Jefferson General Hospital
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- Greater Baltimore Medical Center
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Boston Medical Center
- Mercy Medical Center
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- IHA Hematology Oncology Consultants-Brighton
- Saint Joseph Mercy Brighton
- IHA Hematology Oncology Consultants-Canton
- Saint Joseph Mercy Canton
- Caro Cancer Center
- IHA Hematology Oncology Consultants-Chelsea
- Saint Joseph Mercy Chelsea
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Weisberg Cancer Treatment Center
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum Health
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Hope Cancer Clinic
- Saint Mary Mercy Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Mercy Health Mercy Campus
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton Shores
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Huron Medical Center PC
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Bhadresh Nayak MD PC-Sterling Heights
- Ascension Saint Joseph Hospital
- Munson Medical Center
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- Metro Health Hospital
- Huron Gastroenterology PC
- IHA Hematology Oncology Consultants-Ann Arbor
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Cambridge Medical Center
- Mercy Hospital
- Essentia Health - Deer River Clinic
- Essentia Health Saint Mary's - Detroit Lakes Clinic
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Essentia Health - Fosston
- Unity Hospital
- Essentia Health Hibbing Clinic
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- Monticello Cancer Center
- New Ulm Medical Center
- Essentia Health - Park Rapids
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Essentia Health Sandstone
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Essentia Health Virginia Clinic
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Fairview Lakes Medical Center
- University of Mississippi Medical Center
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Siteman Cancer Center at West County Hospital
- Parkland Health Center - Farmington
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Saint Luke's Hospital of Kansas City
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Mercy Hospital Washington
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Nebraska Hematology and Oncology
- Nebraska Cancer Research Center
- Southeast Nebraska Cancer Center - 68th Street Place
- Faith Regional Health Services Carson Cancer Center
- Great Plains Health Callahan Cancer Center
- Nebraska Methodist Hospital
- Nebraska Cancer Specialists - Omaha
- Oncology Hematology West PC
- Regional West Medical Center Cancer Center
- Carson Tahoe Regional Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven Hills
- 21st Century Oncology-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- Las Vegas Urology - Green Valley
- Las Vegas Urology - Pebble
- Urology Specialists of Nevada - Green Valley
- Las Vegas Urology - Pecos
- Desert West Surgery
- OptumCare Cancer Care at Charleston
- University Medical Center of Southern Nevada
- Hope Cancer Care of Nevada
- Cancer and Blood Specialists-Shadow
- Radiation Oncology Centers of Nevada Central
- Urology Specialists of Nevada - Central
- 21st Century Oncology
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- Sunrise Hospital and Medical Center
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Las Vegas Prostate Cancer Center
- Las Vegas Urology - Sunset
- Urology Specialists of Nevada - Southwest
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- 21st Century Oncology-Vegas Tenaya
- Ann M Wierman MD LTD
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Las Vegas Urology - Cathedral Rock
- Las Vegas Urology - Smoke Ranch
- OptumCare Cancer Care at MountainView
- Urology Specialists of Nevada - Northwest
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
- Comprehensive Cancer Centers of Nevada - Town Center
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- 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
- University Cancer Center
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- University of New Mexico Cancer Center
- New Mexico Cancer Care Alliance
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- State University of New York Upstate Medical University
- SUNY Upstate Medical Center-Community Campus
- AdventHealth Infusion Center Asheville
- Southeastern Medical Oncology Center-Clinton
- AdventHealth Infusion Center Haywood
- 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
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Essentia Health Cancer Center-South University Clinic
- Essentia Health - Jamestown Clinic
- Indu and Raj Soin Medical Center
- Strecker Cancer Center-Belpre
- Saint Elizabeth Boardman Hospital
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- 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
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Dublin Methodist Hospital
- Oncology Hematology Care Inc-Healthplex
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Greater Dayton Cancer Center
- First Dayton Cancer Care
- Kettering Medical Center
- Fairfield Medical Center
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- Dayton Physicians LLC-Signal Point
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Southern Ohio Medical Center
- Dayton Physicians LLC-Wilson
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- Trinity's Tony Teramana Cancer Center
- Dayton Physicians LLC-Upper Valley
- Upper Valley Medical Center
- Saint Joseph Warren Hospital
- Saint Ann's Hospital
- Saint Elizabeth Youngstown Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Oregon Health and Science University
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar Crest
- UPMC-Heritage Valley Health System Beaver
- Lehigh Valley Hospital - Muhlenberg
- Pocono Medical Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Lehigh Valley Hospital-Hazleton
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- UPMC Cancer Center at UPMC McKeesport
- UPMC-Coraopolis/Heritage Valley Radiation Oncology
- Penn Presbyterian Medical Center
- University of Pennsylvania/Abramson Cancer Center
- Fox Chase Cancer Center
- UPMC-Magee Womens Hospital
- UPMC-Presbyterian Hospital
- UPMC-Saint Margaret
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- UPMC Jefferson Regional Radiation Oncology
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- UPMC Cancer Center at UPMC Northwest
- UPMC Uniontown Hospital Radiation Oncology
- UPMC Washington Hospital Radiation Oncology
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Prisma Health Cancer Institute - Easley
- Saint Francis Hospital
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Saint Francis Cancer Center
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- University of Texas Medical Branch
- UTMB Cancer Center at Victory Lakes
- University of Texas Health Science Center at San Antonio
- Farmington Health Center
- Huntsman Cancer Institute/University of Utah
- South Jordan Health Center
- University of Virginia Cancer Center
- Providence Regional Cancer System-Aberdeen
- Cancer Care Center at Island Hospital
- Overlake Medical Center
- PeaceHealth Saint Joseph Medical Center
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Providence Regional Cancer Partnership
- Swedish Cancer Institute-Issaquah
- Providence Regional Cancer System-Lacey
- PeaceHealth Saint John Medical Center
- Valley Medical Center
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Deaconess Cancer and Blood Specialty Center - North
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- Providence Regional Cancer System-Yelm
- Duluth Clinic Ashland
- Northwest Wisconsin Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Marshfield Medical Center-EC Cancer Center
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- Aurora Cancer Care-Kenosha South
- Marshfield Clinic - Ladysmith Center
- Aurora Bay Area Medical Group-Marinette
- Marshfield Medical Center-Marshfield
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- Cancer Center of Western Wisconsin
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Lakeview Medical Center-Marshfield Clinic
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Ascension Saint Michael's Hospital
- Marshfield Clinic Stevens Point Center
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Waukesha
- Marshfield Clinic-Wausau Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Marshfield Medical Center - Weston
- Marshfield Clinic - Wisconsin Rapids Center
- Big Horn Basin Cancer Center
- Billings Clinic-Cody
- Welch Cancer Center
- Tom Baker Cancer Centre
- Cross Cancer Institute
- QEII Health Sciences Centre/Nova Scotia Health Authority
- Saint Joseph's Healthcare Charlton Campus
- London Regional Cancer Program
- Ottawa Hospital and Cancer Center-General Campus
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- CHUM - Centre Hospitalier de l'Universite de Montreal
- Allan Blair Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm I (sunitinib malate)
Arm II (cabozantinib s-malate)
Arm III (crizotinib closed to accrual 12/5/18)
Arm IV (savolitinib closed to accrual 12/5/18)
Patients receive sunitinib malate PO on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients receive cabozantinib s-malate PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients receive crizotinib PO BID on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. At the time of prespecified interim analysis, crizotinib showed a HR for PFS greater than 1 compared with that of sunitinib. The DSMC subsequently recommended that accrual be stopped for this group, and this recommendation was accepted by the NCI.
Patients receive savolitinib PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. At the time of prespecified interim analysis, savolitinib showed a HR for PFS greater than 1 compared with that of sunitinib. The DSMC subsequently recommended that accrual be stopped for this group, and this recommendation was accepted by the NCI.