S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery (S0931)
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, clear cell renal cell carcinoma, papillary renal cell carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma
Clear cell or non-clear cell allowed
- No disease of the collecting duct or medullary carcinoma
- Considered pathologically either intermediate high-risk or very high-risk disease
- No history of distant metastases
- Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible
Have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes
Surgical margins must be negative
- Patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive)
- Patients must be registered within 84 days after the date of the first surgical resection of the first tumor
No evidence of residual or metastatic renal cell cancer on CT scan of the chest, abdomen, and pelvis (all with oral and IV contrast) performed after nephrectomy and within 28 days before registration
- MRI scans of the abdomen and pelvis with gadolinium and a non-contrast CT scan of the chest may be substituted if the patient is not able to have CT scans with IV contrast
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 30 mL/min
- Bilirubin ≤ 1.5 times ULN
- SGOT and SGPT ≤ 2.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment
- Able to take oral medications
Patients must not have any of the following:
- NYHA class III-IV cardiac disease (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort)
- Unstable angina pectoris
- Myocardial infarction within the past 6 months
- Serious uncontrolled cardiac arrhythmia
- Patients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C)
- HBV and HCV testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
- Must be able to take oral medications
- No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- No known history of HIV seropositivity
- No known uncontrolled, underlying pulmonary disease (spirometry and DLCO ≤ 50% of predicted OR oxygen saturation ≤ 88% at rest on room air)
No uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 times ULN) obtained within 28 days prior to registration
- Optimal lipid control must be achieved before registration and monitored during protocol treatment
No uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 times ULN) obtained within 28 days prior to registration.
- Optimal glucose control must be achieved before registration and monitored during protocol treatment
No prior malignancies except for any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or stage II cancer from which the patient is currently in complete remission
- Any other cancer from which the patient has been disease-free for 5 years
- No known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients
- No contraindications to receiving either IV iodine-based contrast or gadolinium
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Patients must have recovered from any surgery-related complications
- No prior anticancer therapy for renal cell carcinoma including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiotherapy
- More than 14 days since prior and no concurrent strong CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, voriconazole, posaconazole, fluvoxamine, nefazodone, nelfinavir, or ritonavir) or strong CYP3A4 inducers (i.e., phenytoin, rifampin, or rifabutin)
- More than 7 days since prior and no concurrent live vaccines
- No other concurrent anticancer agents including investigational agents
No concurrent chronic treatment with systemic steroids or another immunosuppressive agent
- Topical or inhaled corticosteroids are allowed
Sites / Locations
- University of Alabama at Birmingham
- Gulf Coast MBCCOP
- Providence Hospital
- University of South Alabama Mitchell Cancer Institute
- Fairbanks Memorial Hospital
- Arizona Cancer Center at UMC Orange Grove
- Arizona Cancer Center at University Medical Center North
- University of Arizona Health Sciences Center
- Fowler Family Center for Cancer Care
- University of Arkansas for Medical Sciences
- Veteran's Administration Medical Center
- Kaiser Anaheim Medical Center
- Sutter Auburn Faith Hospital
- Kaiser Permanente Medical Group - Baldwin Park
- Kaiser Foundation Hospital
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills - Peninsula Hospitals
- East Bay Radiation Oncology Center
- Valley Medical Oncology Consultants-Castro Valley
- City of Hope Comprehensive Cancer Center
- Epic Care-Dublin
- Northbay Cancer Center
- Kaiser Permanente Hospital
- Valley Medical Oncology Consultants-Fremont
- Washington Hospital
- Saint Jude Medical Center
- Glendale Memorial Hospital and Health Center
- Marin Cancer Care Inc
- Marin General Hospital
- Kaiser Permanente - Harbor City
- Southern California Permanente Medical Group
- UC San Diego Moores Cancer Center
- Long Beach Memorial Medical Center-Todd Cancer Institute
- Kaiser Permanente Los Angeles Medical Center
- Kaiser Permanente
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Kaiser Permanente-West Los Angeles
- Cedars-Sinai Medical Center
- Contra Costa Regional Medical Center
- Fremont - Rideout Cancer Center
- Mercy UC Davis Cancer Center
- Memorial Medical Center
- El Camino Hospital
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons Inc
- Bay Area Tumor Institute
- Larry G Strieff MD Medical Corporation
- Tom K Lee Inc
- Epic Care-Oakland
- Palo Alto Medical Foundation Health Care
- Kaiser Permanente - Panorama City
- Valley Medical Oncology Consultants
- Eisenhower Medical Center
- Kaiser Permanente Medical Center
- Sutter Roseville Medical Center
- Sutter General Hospital
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-Mission
- Kaiser Permanente at San Diego
- Kaiser Permanente
- UCSF Medical Center-Mount Zion
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente Health Care
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Palo Alto Medical Foundation-Santa Cruz
- Sutter Pacific Medical Foundation
- Palo Atlo Medical Foundation-Sunnyvale
- Tahoe Forest Cancer Center
- Sutter Solano Medical Center/Cancer Center
- Presbyterian Intercommunity Hospital
- Kaiser Permanente
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Memorial Hospital Colorado Springs
- Porter Adventist Hospital
- Exempla Saint Joseph Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- Denver Veterans Administration Medical Center
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Colorado Cancer Research Program CCOP
- Colorado Blood Cancer Institute
- Mercy Medical Center
- Southwest Oncology PC
- The Shaw Regional Cancer Center
- Comprehensive Cancer Care and Research Institute of Colorado LLC
- Swedish Medical Center
- Poudre Valley Hospital
- Valley View Hospital Cancer Center
- Mountain Blue Cancer Care Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- North Suburban Medical Center
- Rocky Mountain Cancer Centers-Thornton
- Exempla Lutheran Medical Center
- Danbury Hospital
- University of Connecticut
- Saint Francis Hospital and Medical Center
- Manchester Memorial Hospital
- Middlesex Hospital
- The Hospital of Central Connecticut
- Yale University
- Eastern Connecticut Hematology and Oncology Associates
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Regional Hematology and Oncology PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Nanticoke Memorial Hospital
- Christiana Care Health System-Wilmington Hospital
- Washington Hospital Center
- George Washington University Medical Center
- Lombardi Comprehensive Cancer Center at Georgetown University
- Florida Hospital Cancer Institute Altamonte
- Holy Cross Hospital
- Jupiter Medical Center
- Florida Hospital Kissimmee
- Lakeland Regional Cancer Center
- The Watson Clinic
- Mount Sinai Medical Center
- Florida Hospital Orlando
- Florida Urology Associates-Orlando
- UF Cancer Center at Orlando Health
- Florida Hospital East Orlando
- Sacred Heart Hospital
- Sacred Heart Medical Oncology Group - Davis Highway
- Cleveland Clinic Florida - Weston
- Florida Hospital Cancer Institute Winter Park
- Phoebe Putney Memorial Hospital
- University Cancer and Blood Center LLC
- Piedmont Hospital
- Emory University/Winship Cancer Institute
- Atlanta Regional CCOP
- Northside Hospital
- Saint Joseph's Hospital of Atlanta
- Georgia Regents University Medical Center
- Well Star Cobb Hospital
- John B Amos Cancer Center
- Dekalb Medical Center
- Piedmont Fayette Hospital
- Gwinnett Medical Center
- Medical Center of Central Georgia
- Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Medical Oncology and Clinical Research
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- South Georgia Medical Center
- Oncare Hawaii Inc-Pali Momi
- Pali Momi Medical Center
- Leeward Radiation Oncology Center
- Oncare Hawaii Inc-POB II
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- OnCare Hawaii-Liliha
- Kuakini Medical Center
- Oncare Hawaii Inc-Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Castle Medical Center
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Mountain States Tumor Institute
- Kootenai Medical Center
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Saint Joseph Regional Medical Center
- Idaho Urologic Institute-Meridian
- Saint Luke's Mountain States Tumor Institute - Meridian
- Saint Luke's Mountain States Tumor Institute - Nampa
- Kootenai Cancer Center
- Kootenai Cancer
- Saint Luke's Mountain States Tumor Institute-Twin Falls
- Saint Anthony's Health
- Rush - Copley Medical Center
- Mac Neal Hospital
- Illinois CancerCare-Bloomington
- Saint Joseph Medical Center
- Graham Hospital Association
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- Illinois CancerCare-Carthage
- Memorial Hospital
- Centralia Oncology Clinic
- University of Illinois
- Resurrection Healthcare
- University of Chicago Comprehensive Cancer Center
- Weiss Memorial Hospital
- Carle on Vermilion
- Cancer Care Center of Decatur
- Central Illinois CCOP
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Eureka Hospital
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare Galesburg
- Illinois CancerCare-Galesburg Cottage Plaza Office
- Western Illinois Cancer Treatment Center
- Cadence Cancer Center at Delnor
- NorthShore University HealthSystem-Glenbrook Hospital
- Illinois CancerCare-Havana
- Mason District Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Hines Veterans Administration Hospital
- Joliet Oncology-Hematology Associates Limited
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- Adventist La Grange Memorial Hospital
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- Edward Hospital/Cancer Center
- UC Comprehensive Cancer Center at Silver Cross
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Illinois CancerCare-Community Cancer Center
- Mid-Illinois Hematology Oncology Associates
- Advocate Christ Medical Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- Pekin Cancer Treatment Center
- Methodist Medical Center of Illinois
- Proctor Hospital
- OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- West Suburban Medical Center
- SwedishAmerican Regional Cancer Center/ACT
- Illinois CancerCare-Spring Valley
- Central Illinois Hematology Oncology Center
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Cadence Cancer Center in Warrenville
- Rush-Copley Healthcare Center
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Indiana University/Melvin and Bren Simon Cancer Center
- Richard L. Roudebush Veterans Affairs Medical Center
- Franciscan Saint Francis Health-Indianapolis
- Community Howard Regional Health
- IU Health La Porte Hospital
- Premier Oncology Hematology Associates
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Cancer Care Partners LLC
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- The Community Hospital
- Michiana Hematology Oncology PC-Plymouth
- Reid Hospital and Health Care Services
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology-PC Westville
- Mary Greeley Medical Center
- McFarland Clinic PC-William R Bliss Cancer Center
- Hematology Oncology Associates-Quad Cities
- McFarland Clinic PC-Boone
- Cedar Rapids Oncology Association
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Genesis Medical Center - East Campus
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- McFarland Clinic PC-Trinity Cancer Center
- University of Iowa Hospitals and Clinics
- McFarland Clinic PC-Jefferson
- McFarland Clinic PC-Marshalltown
- Mercy Medical Center - North Iowa
- Siouxland Hematology Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Newman Regional Health
- Cancer Center of Kansas - Fort Scott
- Saint Catherine Hospital
- Saint Rose Ambulatory and Surgery Center
- Hays Medical Center
- Promise Regional Medical Center-Hutchinson
- Cancer Center of Kansas-Independence
- Kansas City Cancer Center-West
- Providence Medical Center
- University of Kansas Medical Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas-Manhattan
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Olathe Medical Center
- Menorah Medical Center
- Kansas City Cancer Centers-Southwest
- Saint Luke's South Hospital
- Cancer Center of Kansas - Parsons
- Via Christi Hospital-Pittsburg
- Kansas City CCOP
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Kansas City Cancer Center-Shawnee Mission
- Stormont-Vail Regional Health Center
- Saint Francis Hospital and Medical Center - Topeka
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wesley Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Oncology Hematology Care Inc-Crestview
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- Jewish Hospital Medical Center Northeast
- Owensboro Health Mitchell Memorial Cancer Center
- Jewish Hospital Medical Center South
- Mary Bird Perkins Cancer Center
- East Jefferson General Hospital
- Robert Veith MD LLC
- Louisiana State University Sciences Center- Monroe
- Interim LSU Public Hospital
- Louisiana State University Health Science Center
- Ochsner Medical Center Jefferson
- Louisiana State University Health Sciences Center Shreveport
- Highland Clinic
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Penobscot Bay Medical Center
- York Hospital
- University of Maryland/Greenebaum Cancer Center
- Veterans Administration Medical Center-Baltimore
- Greater Baltimore Medical Center
- Walter Reed National Military Medical Center
- The Memorial Hospital at Easton
- Union Hospital of Cecil County
- Associates In Oncology Hematology PC-Rockville
- Peninsula Regional Medical Center
- Holy Cross Hospital
- Beverly Hospital
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- Boston Medical Center
- Beth Israel Deaconess Medical Center
- Caritas Saint Elizabeth's Medical Center
- Lahey Hospital and Medical Center
- Addison Gilbert Hospital
- Lowell General Hospital
- Holy Family Hospital
- Baystate Medical Center
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium Community Clinical Oncology Program
- University of Michigan University Hospital
- University of Michigan
- Bronson Battle Creek
- McLaren-Bay Region
- Spectrum Health Big Rapids Hospital
- Great Lakes Cancer Institute
- Oakwood Hospital and Medical Center
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Saint John Hospital and Medical Center
- Green Bay Oncology - Escanaba
- Weisberg Cancer Treatment Center
- Hurley Medical Center
- Genesys Hurley Cancer Institute
- Genesys Regional Medical Center-West Flint Campus
- Singh and Arora Hematology Oncology PC
- Genesys Regional Medical Center
- Grand Rapids Clinical Oncology Program
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Sparrow Hospital
- Great Lakes Cancer Institute-Lapeer Campus
- Saint Mary Mercy Hospital
- Community Cancer Center of Monroe
- Mercy Memorial Hospital
- Mercy Health Mercy Campus
- Lakeland Community Hospital
- Northern Michigan Regional Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Spectrum Health Reed City Hospital
- William Beaumont Hospital-Royal Oak
- Saint Mary's of Michigan
- Lakeland Hospital
- Marie Yeager Cancer Center
- Munson Medical Center
- William Beaumont Hospital - Troy
- Saint John Macomb-Oakland Hospital
- Metro Health Hospital
- Medini, Eitan MD (UIA Investigator)
- Sanford Clinic North-Bemidgi
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview-Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Minneapolis Veterans Medical Center
- Health Partners Inc
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- Coborn Cancer Center at Saint Cloud Hospital
- Saint Cloud Hospital
- Metro-Minnesota CCOP
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology and Hematology PA-Woodbury
- Forest General Hospital
- University of Mississippi Medical Center
- Central Care Cancer Center-Carrie J Babb Cancer Center
- Parkland Health Center-Bonne Terre
- CoxHealth Cancer Center
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- Centerpoint Medical Center LLC
- Capital Region Medical Center-Goldschmidt Cancer Center
- Freeman Health System
- Mercy Hospital-Joplin
- Truman Medical Center
- Saint Luke's Cancer Institute
- Saint Luke's Hospital of Kansas City
- North Kansas City Hospital
- Heartland Hematology and Oncology Associates Incorporated
- Kansas City Cancer Center - South
- Research Medical Center
- Kansas City Cancer Centers - North
- Kansas City Cancer Center-Lee's Summit
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Phelps County Regional Medical Center
- Saint John's Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Joseph Oncology Inc
- Saint Louis Cancer and Breast Institute-South City
- Saint Louis University Hospital
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Barnes-Jewish West County Hospital
- Comprehensive Cancer Care PC
- Saint John's Mercy Medical Center
- Saint Louis-Cape Girardeau CCOP
- Siteman Cancer Center - Saint Peters
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Montana Cancer Consortium CCOP
- Saint Vincent Healthcare
- Frontier Cancer Center and Blood Institute-Billings
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Big Sky Oncology
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Hospital
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Saint Francis Medical Center
- Heartland Hematology and Oncology
- Good Samaritan Hospital
- Saint Elizabeth Regional Medical Center
- Alegent Health Immanuel Medical Center
- Hemotology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- University of Nebraska Medical Center
- Midlands Community Hospital
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- 21st Century Oncology - Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Shadow
- Nevada Cancer Research Foundation CCOP
- Radiation Oncology Centers of Nevada Central
- 21st Century Oncology - Vegas Sunrise
- Children's Specialty Center of Nevada II
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- Sunrise Hospital and Medical Center
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- 21st Century Oncology - Fort Apache
- Cancer and Blood Specialists-Fort Apache
- Comprehensive Cancer Centers of Nevada
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- 21st Century Oncology - Vegas Tenaya
- Renown Regional Medical Center
- Alpine Hematology-Oncology
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- Reno Oncology Consultants
- New Hampshire Oncology-Hematology PA
- New Hampshire Oncology Hematology Associates
- LRGHealthcare-Lakes Region General Hospital
- Dartmouth Hitchcock Medical Center
- Portsmouth Regional Hospital
- Cooper Hospital University Medical Center
- Veterans Adminstration New Jersey Health Care System
- Englewood Hospital and Medical Center
- CentraState Medical Center
- Cancer Institute of New Jersey At Hamilton
- Saint Barnabas Medical Center
- Morristown Memorial Hospital
- Saint Peter's University Hospital
- Rutgers Cancer Institute of New Jersey
- UMDNJ - Robert Wood Johnson University Hospital
- Kennedy Health Systems-Cancer Center
- Robert Wood Johnson University Hospital Somerset
- Overlook Hospital
- Inspira Medical Center Vineland
- MD Anderson Cancer Center at Cooper-Voorhees
- Inspira Medical Center Woodbury
- Hematology Oncology Associates
- Presbyterian Kaseman Hospital
- New Mexico Cancer Care Associates
- Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus
- Mary Imogene Bassett Hospital
- Glens Falls Hospital
- Orange Regional Medical Center
- Winthrop University Hospital
- New York University Langone Medical Center
- Columbia University Medical Center
- Weill Medical College of Cornell University
- Rochester General Hospital
- University of Rochester
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Dickstein Cancer Treatment Center
- Cancer Care of Western North Carolina
- Mission Hospital-Memorial Campus
- Mountain Radiation Oncology
- Asheville Hematology-Oncology Associates
- Hope Women's Cancer Centers-Asheville
- Transylvania Regional Hospital
- Carolinas Medical Center
- Sampson Radiation Oncology
- Southeastern Medical Oncology Center-Clinton
- Carolinas Medical Center - Northeast
- Angel Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- Park Ridge Hospital Breast Health Center
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Novant Health Oncology Specialists-Kernersville
- Kinston Medical Specialists PA
- Novant Health Oncology Specialists-Davidson County
- McDowell Hospital
- Carolinas Medical Center-Union
- Novant Health Oncology Specialists-Mount Airy
- FirstHealth of the Carolinas-Moore Regional Hosiptal
- Cleveland Regional Medical Center
- Blue Ridge Regional Hospital
- Novant Health Oncology Specialists-Statesville
- Novant Health Oncology Specialists-Wilkesboro
- Southeastern Medical Oncology Center-Wilson
- Novant Health Forsyth Medical Center
- Novant Health Oncology Specialists
- Winston-Salem Health Care
- Southeast Cancer Control Consortium CCOP
- Wake Forest University Health Sciences
- Bismarck Cancer Center
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Roger Maris Cancer Center
- Sanford Clinic North-Fargo
- Sanford Medical Center-Fargo
- Altru Cancer Center
- Summa Akron City Hospital/Cooper Cancer Center
- Akron General Medical Center
- Summa Barberton Hospital
- Mary Rutan Hospital
- Strecker Cancer Center-Belpre
- Toledo Clinic Cancer Centers-Bowling Green
- Aultman Health Foundation
- Miami Valley Hospital South
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Mercy West
- Oncology and Hematology Care Inc-Taft
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc - Anderson
- Oncology Hematology Care Inc - Kenwood
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- University of Cincinnati
- MetroHealth Medical Center
- North Coast Cancer Care-Clyde
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Columbus CCOP
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Dayton CCOP
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Hematology Oncology Center Incorporated
- Mercy Cancer Center-Elyria
- Oncology Hematology Care Inc-Healthplex
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Lancaster Radiation Oncology
- Lima Memorial Hospital
- Marietta Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Summa Health Center at Lake Medina
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- Fisher-Titus Medical Center
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Southern Ohio Medical Center
- North Coast Cancer Care
- Springfield Regional Medical Center
- Trinity's Tony Teramana Cancer Center
- Flower Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- University Pointe
- Saint Ann's Hospital
- Clinton Memorial Hospital
- Wright-Patterson Medical Center
- Greene Memorial Hospital
- Genesis HealthCare System
- Cancer Centers of Southwest Oklahoma Research
- Cancer Care Associates-Norman
- University of Oklahoma Health Sciences Center
- Cancer Care Associates-Mercy
- Oklahoma Oncology Inc
- Natalie Warren Bryant Cancer Center at Saint Francis
- Warren Cancer Research Foundation
- Tulsa Cancer Institute
- Saint Charles Medical Center-Bend
- Bay Area Hospital
- Three Rivers Community Hospital
- Legacy Mount Hood Medical Center
- Asante Health System
- Providence Medford Medical Center
- Rogue Valley Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Kaiser Permanente
- Legacy Emanuel Hospital and Health Center
- Oregon Health and Science University
- Salem Hospital
- Legacy Meridian Park Hospital
- Abington Memorial Hospital
- Lehigh Valley Hospital
- UPMC - HVHS Cancer Center at Heritage Valley Beaver
- Lehigh Valley Hospital - Muhlenberg
- Bryn Mawr Hospital
- Butler Memorial Hospital
- UPMC Cancer Center at Jefferson Regional Medical Center
- Geisinger Medical Center
- Doylestown Hospital
- Delaware County Memorial Hospital
- Easton Hospital
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Milton S Hershey Medical Center
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Lancaster General Hospital
- Geisinger Medical Oncology at Evangelical Community Hospital
- Lewistown Hospital
- UPMC Cancer Center at UPMC McKeesport
- UPMC-Coraopolis/Heritage Valley Radiation Oncology
- Paoli Memorial Hospital
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- Magee-Womens Hospital of UPMC
- University of Pittsburgh Medical Center-Presbyterian Hospital
- UPMC-Saint Margaret
- University of Pittsburgh
- UPMC-Shadyside Hospital
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- Pottstown Memorial Medical Center
- Geisinger Medical Oncology-Pottsville
- Guthrie Medical Group PC-Robert Packer Hospital
- Grand View Hospital
- UPMC Cancer Center at UPMC Northwest
- Geisinger Medical Group
- UPMC-Uniontown/Robert E. Eberly Pavilion
- Washington Hospital
- Chester County Hospital
- Reading Hospital
- Geisinger Wyoming Valley
- Susquehanna Cancer Center
- Lankenau Medical Center
- Mainline Health CCOP
- AnMed Health Cancer Center
- AnMed Health Hospital
- Roper Hospital
- Charleston Hematology Oncology Associates-Roper
- Lowcountry Hematology Oncology PA-Charleston
- Charleston Hematology Oncology Associates PA-St. Francis
- Lowcountry Hematology Oncology PA-West Ashley
- Medical University of South Carolina
- Greenville Health System Cancer Institute-Easley
- McLeod Regional Medical Center
- Saint Francis Hospital
- Greenville Health System Cancer Institute-Andrews
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Saint Francis Cancer Center
- Greenville Health System Cancer Institute-Eastside
- Self Regional Healthcare
- Greenville Health System Cancer Institute-Greer
- Gibbs Cancer Center-Pelham
- Carolina Blood and Cancer Care Associates PA-Lancaster
- Lowcountry Hematology Oncology PA-Mount Pleasant
- Carolina Blood and Cancer Care Associates PA
- Greenville Health System Cancer Institute-Seneca
- Spartanburg Regional Medical Center
- Upstate Carolina CCOP
- Greenville Health System Cancer Institute-Spartanburg
- Conklin Regional Cancer Center
- Rapid City Regional Hospital
- Sanford Cancer Center-Oncology Clinic
- Avera Cancer Institute
- Medical X-Ray Center
- Sanford USD Medical Center - Sioux Falls
- Wellmont Bristol Regional Medical Center
- Wellmont Medical Associates Oncology and Hematology-Bristol
- Erlanger Medical Center
- Memorial Hospital
- Vanderbilt-Ingram Cancer Center Cool Springs
- Pulmonary Medicine Center of Chattanooga-Hixson
- Wellmont Holston Valley Hospital and Medical Center
- Wellmont Medical Associates Oncology and Hematology-Kingsport
- University of Tennessee - Knoxville
- University of Tennessee Health Science Center
- Meharry Medical College
- Vanderbilt-Ingram Cancer Center
- Memorial GYN Plus
- University of Texas Medical Branch at Galveston
- Baylor College of Medicine
- Ben Taub General Hospital
- Saint Luke's Episcopal Hospital
- Veterans Administration Medical Center
- UTMB Cancer Center at Victory Lakes
- Covenant Medical Center-Lakeside
- Audie L Murphy Veterans Affairs Hospital
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
- University Hospital
- University of Texas Health Science Center at San Antonio
- Scott and White Memorial Hospital
- Huntsman Cancer Institute/University of Utah
- Danville Hematology Oncology
- Danville Regional Medical Center
- Fredericksburg Oncology Inc
- Hematology Oncology Associates of Fredericksburg Inc
- Lynchburg Hematology-Oncology Clinic
- Bon Secours Saint Francis Medical Center
- Southwest VA Regional Cancer Center
- Bon Secours Saint Mary's Hospital
- Virginia Cancer Institute
- Virginia Commonwealth University/Massey Cancer Center
- Community Memorial Health Center
- Shenandoah Oncology Associates PC
- Cancer Care Center at Island Hospital
- Auburn Regional Medical Center
- Overlake Hospital Medical Center
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Medical Center-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- EvergreenHealth Medical Center
- Seattle Cancer Care Alliance at EvergreenHealth
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- Skagit Valley Hospital
- Providence - Saint Peter Hospital
- Capital Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- MultiCare Good Samaritan Hospital
- Virginia Mason CCOP
- Virginia Mason Medical Center
- Harborview Medical Center
- Minor and James Medical PLLC
- Pacific Medical Center-First Hill
- Swedish Medical Center-Ballard Campus
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- Group Health
- Group Health Cooperative-Seattle
- Swedish Medical Center-First Hill
- The Polyclinic
- University of Washington Medical Center
- United General Hospital
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology PS
- Rockwood Clinic
- Franciscan Research Center-Northwest Medical Plaza
- MultiCare Allenmore Hospital
- Northwest CCOP
- Northwest Medical Specialties PLLC
- Saint Joseph Medical Center
- Multicare Health System
- Madigan Army Medical Center
- Legacy Salmon Creek Hospital
- Providence Saint Mary Regional Cancer Center
- Wenatchee Valley Medical Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- West Virginia University Charleston
- Edwards Comprehensive Cancer Center
- Saint Mary's Medical Center
- Langlade Hospital and Cancer Center
- Fox Valley Hematology and Oncology
- Aurora Cancer Care-Burlington
- Marshfield Clinic Cancer Center at Sacred Heart
- Sacred Heart Hospital
- Aurora Cancer Care-Southern Lakes
- Aurora Health Center-Fond du Lac
- Aurora Cancer Care-Grafton
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- Aurora BayCare Medical Center
- UW Cancer Center Johnson Creek
- Aurora Cancer Care-Kenosha South
- Gundersen Lutheran Medical Center
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Vince Lombardi Cancer Clinic-Marinette
- Marshfield Clinic
- Saint Joseph's Hospital
- Aurora Advanced Healthcare Inc-Menomonee Falls
- Community Memorial Hospital
- Aurora Cancer Care-Milwaukee
- Wheaton Franciscan Healthcare - Saint Joseph
- Aurora Cancer Care-Milwaukee South
- Aurora Saint Luke's Medical Center
- Froedtert and the Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- D N Greenwald Center
- Cancer Center of Western Wisconsin
- Oconomowoc Memorial Hospital-ProHealth Care Inc
- Green Bay Oncology - Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Marshfield Clinic at James Beck Cancer Center
- Saint Mary's Hospital
- Marshfield Clinic-Rice Lake Center
- Saint Nicholas Hospital
- Vince Lombardi Cancer Clinic-Sheboygan
- Marshfield Clinic Cancer Care at Saint Michael's Hospital
- Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic
- Aurora Cancer Care-Waukesha
- Waukesha Memorial Hospital - ProHealth Care
- Aspirus Regional Cancer Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- The Alyce and Elmore Kraemer Cancer Care Center
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Riverview Hospital
- Rocky Mountain Oncology
- Cheyenne Regional Medical Center-West
- Big Horn Basin Cancer Center
- Billings Clinic-Cody
- Welch Cancer Center
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I
Arm II
Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.