Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy
NCT ID: NCT01198158
Last Updated: 2019-03-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
77 participants
INTERVENTIONAL
2010-09-15
2017-12-16
Brief Summary
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Detailed Description
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l. To compare the overall survival of patients receiving bevacizumab plus everolimus and everolimus alone among patients with advanced renal cell carcinoma progressing after first line vascular epidermal growth factor receptor (VEGFR)-tyrosine kinase inhibitor (TKI) treatment.
SECONDARY OBJECTIVES:
I. To compare the progression-free survival and proportion who experience an objective response (defined as complete clinical response \[cCR\] + partial response \[PR\]) in patients with advanced renal cell carcinoma receiving bevacizumab plus everolimus and everolimus alone.
II. To compare grade 3 or higher toxicity in patients receiving each treatment regimen.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive everolimus orally (PO) once daily (QD) on days 1-28.
ARM II: Patients receive everolimus PO QD on days 1-28 and bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 8 weeks until disease progression and then every 6 months for up to 5.5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm I (everolimus)
Patients receive everolimus PO QD on days 1-28.
Everolimus
Given PO
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Arm II (everolimus with bevacizumab)
Patients receive everolimus PO QD on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15.
Bevacizumab
Given IV
Everolimus
Given PO
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Interventions
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Bevacizumab
Given IV
Everolimus
Given PO
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic or unresectable disease
* Must have been treated with at least 1 prior VEGFR tyrosine kinase inhibitor treatment and have progressed or have been intolerant to treatment
* No prior systemic therapy with a vascular endothelial growth factor (VEGF) binding agent (e.g., bevacizumab)
* No prior systemic therapy with any mechanistic target of rapamycin (mTOR) inhibitor (e.g., sirolimus, temsirolimus, everolimus)
* Prior cytokine therapy is allowed
* Any systemic therapy must be completed at least 4 weeks prior to registration
* \>= 2 weeks since any prior radiation (including palliative)
* Patients must not have had a major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to study registration, and must have fully recovered from any such procedure
* The following are not considered to be major procedures: thoracentesis, paracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic ultrasonographic procedures, mediastinoscopy, skin biopsies, incisional biopsies and routine dental procedures
* Patients must have measurable disease by 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 day 1 are not eligible
* Baseline brain imaging (MRI/CT) is required
* No serious non-healing wound, ulcer, or bone fracture
* No arterial thrombotic events within 6 months of registration:
* Including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, unstable angina or angina requiring surgical or medical intervention in the past 6 months, 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
* Patients who have experienced a deep venous thrombosis or pulmonary embolus within the past 6 months must be on stable therapeutic anticoagulation to be enrolled to this study
* Patients receiving anti-platelet agents and prophylactic anticoagulation are eligible
* No inadequately controlled hypertension: (defined as a blood pressure of \>= 160 mmHg systolic and/or \>= 90 mmHg diastolic on medication), or any prior history of hypertensive crisis or hypertensive encephalopathy
* No known severe impairment of lung function, defined as \>= grade 2 dyspnea or cough, or either:
* Requirement of supplemental oxygen, or
* In cases where pulmonary function or pulse oximetry tests have been obtained, forced expiratory volume of the lung in one second (FEV1) or forced vital capacity (FVC) are \< 50% of predicted, or single breath diffusing capacity of the lung for carbon monoxide (DLCO) is \< 35% of predicted or resting room oxygen saturation is less than 90%
* No active or severe liver disease (e.g. acute or chronic hepatitis, cirrhosis)
* No positive serology for anti-hemoglobin C (HBC) or anti-hepatitis C virus (HCV) antibodies; hepatitis B virus (HBV) seropositive patients (hepatitis B surface antigen \[HBsAg\] positive) are eligible if they are closely monitored for evidence of active HBV infection by HBV deoxryribonucleic acid (DNA) testing and agree to receive suppressive therapy with lamivudine or other HBV-suppressive therapy until at least 4 weeks after the last dose of everolimus
* No New York Heart Association (NYHA) class \>= 2 congestive heart failure
* No active bleeding or chronic hemorrhagic diathesis or increased risk for bleeding: Including but not limited to history of major bleeding within 6 months (e.g. gastrointestinal, lung, CNS sites; or required transfusion support)
* No history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to the initiation of treatment
* No ongoing immunosuppressive therapy: including chronic systemic treatment with corticosteroids (\>= 10 mg/day prednisone equivalent)
* Archival tissue must be available for submission: though it is optional patients to choose to participate in the correlative substudies or not
* 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 or Karnofsky score \>= 60%
* Granulocytes \>= 1,500/μL
* Platelet count \>= 100,000/μL
* Calculated creatinine clearance \>= 30 mL/minute (modified Cockroft and Gault formula)
* Bilirubin =\< 1.5 x upper limits of normal
* Aspartate aminotransferase (AST) =\< 2.5 x upper limits of normal (ULN)
* Fasting serum triglycerides =\< 200 mg/dL
* Serum cholesterol =\< 300 mg/dL
* Fasting serum glucose =\< 1.5 x ULN
* Urine protein to creatinine ratio \< 1.0 or urine protein =\< 1+
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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George Philips
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Fowler Family Center for Cancer Care
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim
Anaheim, California, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
PCR Oncology
Arroyo Grande, California, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States
Kaiser Permanente-Bellflower
Bellflower, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Mills-Peninsula Medical Center
Burlingame, California, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Epic Care Partners in Cancer Care
Emeryville, California, United States
Kaiser Permanente-Fontana
Fontana, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
Kaiser Permanente - Harbor City
Harbor City, California, United States
Kaiser Permanente-Irvine
Irvine, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Kaiser Permanente-Cadillac
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Memorial Medical Center
Modesto, California, United States
El Camino Hospital
Mountain View, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
Highland General Hospital
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Hematology and Oncology Associates-Oakland
Oakland, California, United States
Tom K Lee Inc
Oakland, California, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Kaiser Permanente - Panorama City
Panorama City, California, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Kaiser Permanente-Riverside
Riverside, California, United States
Rohnert Park Cancer Center
Rohnert Park, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
South Sacramento Cancer Center
Sacramento, California, United States
Kaiser Permanente - Sacramento
Sacramento, California, United States
Kaiser Permanente-San Diego Mission
San Diego, California, United States
Kaiser Permanente-San Diego Zion
San Diego, California, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Marcos
San Marcos, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States
Kaiser Permanente-San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Stockton
Stockton, California, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Kaiser Permanente-Franklin
Denver, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Colorado Cancer Research Program NCORP
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Littleton Adventist Hospital
Littleton, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Parker Adventist Hospital
Parker, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
21st Century Oncology-Orange Park
Orange Park, Florida, United States
Florida Hospital Orlando
Orlando, Florida, United States
UF Cancer Center at Orlando Health
Orlando, Florida, United States
Sacred Heart Hospital
Pensacola, Florida, United States
Cleveland Clinic-Weston
Weston, Florida, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Castle Medical Center
Kailua, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Maui Memorial Medical Center
Wailuku, Hawaii, United States
Pacific Cancer Institute of Maui
Wailuku, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Graham Hospital Association
Canton, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Presence Resurrection Medical Center
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Weiss Memorial Hospital
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Heartland Cancer Research NCORP
Decatur, Illinois, United States
Eureka Hospital
Eureka, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Illinois CancerCare-Havana
Havana, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Presence Saint Mary's Hospital
Kankakee, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
AMITA Health Adventist Medical Center
La Grange, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Mcdonough District Hospital
Macomb, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Holy Family Medical Center
Monmouth, Illinois, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center Foundation
Normal, Illinois, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois Valley Hospital
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
West Suburban Medical Center
River Forest, Illinois, United States
Swedish American Hospital
Rockford, Illinois, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, United States
Elkhart Clinic
Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Premier Oncology Hematology Associates
Merrillville, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Reid Health
Richmond, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States
Saint Luke's Hospital
Cedar Rapids, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Iowa City VA Healthcare System
Iowa City, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Methodist West Hospital
West Des Moines, Iowa, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States
Providence Medical Center
Kansas City, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Saint Luke's South Hospital
Overland Park, Kansas, United States
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States
Shawnee Mission Medical Center-KCCC
Shawnee Mission, Kansas, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
University Health-Conway
Monroe, Louisiana, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States
Highland Clinic
Shreveport, Louisiana, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Steward Saint Elizabeth's Medical Center
Brighton, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Berkshire Hematology Oncology PC
Pittsfield, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Bixby Medical Center
Adrian, Michigan, United States
Hickman Cancer Center
Adrian, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
McLaren Cancer Institute-Bay City
Bay City, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
McLaren Cancer Institute-Flint
Flint, Michigan, United States
Singh and Arora Hematology Oncology PC
Flint, Michigan, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, United States
Mercy Memorial Hospital
Monroe, Michigan, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Lakeland Hospital Niles
Niles, Michigan, United States
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Medini, Eitan MD (UIA Investigator)
Alexandria, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Minneapolis Veterans Medical Center
Minneapolis, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Cox Cancer Center Branson
Branson, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Saint Luke's Hospital
Chesterfield, Missouri, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Capital Region Southwest Campus
Jefferson City, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
Truman Medical Center
Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Saint Joseph Health Center
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Liberty Radiation Oncology Center
Liberty, Missouri, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Comprehensive Cancer Care PC
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Montana Cancer Consortium NCORP
Billings, Montana, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Glacier Oncology PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
CHI Health Saint Francis
Grand Island, Nebraska, United States
CHI Health Good Samaritan
Kearney, Nebraska, United States
Great Plains Health Callahan Cancer Center
North Platte, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Virtua Memorial
Mount Holly, New Jersey, United States
Virtua Voorhees
Voorhees Township, New Jersey, United States
Veterans Affairs Western New York Health Care System-Buffalo
Buffalo, New York, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Orange Regional Medical Center
Middletown, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Mission Hospital Inc-Memorial Campus
Asheville, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Carolinas HealthCare System NorthEast
Concord, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Vidant Oncology-Kinston
Kinston, North Carolina, United States
Marion L Shepard Cancer Center at Vidant Beaufort Hospital
Washington, North Carolina, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Saint Alexius Medical Center
Bismarck, North Dakota, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
Summa Barberton Hospital
Barberton, Ohio, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
Mercy Medical Center
Canton, Ohio, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, United States
North Coast Cancer Care-Clyde
Clyde, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Health Center
Dayton, Ohio, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Saint Rita's Medical Center
Lima, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Saint Luke's Hospital
Maumee, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States
Fisher-Titus Medical Center
Norwalk, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
North Coast Cancer Care
Sandusky, Ohio, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Clinton Memorial Hospital
Wilmington, Ohio, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, United States
Cancer Care Associates-Norman
Norman, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Mercy Physicians of Oklahoma-Lakeside
Oklahoma City, Oklahoma, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Adventist Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Compass Oncology Rose Quarter
Portland, Oregon, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Mid-Columbia Medical Center/Celilo Cancer Center
The Dalles, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Butler Memorial Hospital
Butler, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Ephrata Cancer Center
Ephrata, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
Riddle Memorial Hospital
Media, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States
Hematology and Oncology Associates of North East Pennsylvania
Scranton, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Associates In Hematology Oncology PC-Upland
Upland, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
UPMC Susquehanna
Williamsport, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, United States
Roper Hospital
Charleston, South Carolina, United States
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont College of Medicine
Burlington, Vermont, United States
White River Junction Veteran Administration Medical Center
White River Junction, Vermont, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg, Virginia, United States
Southwest VA Regional Cancer Center
Norton, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Saint Francis Hospital
Federal Way, Washington, United States
Saint Clare Hospital
Lakewood, Washington, United States
Providence - Saint Peter Hospital
Olympia, Washington, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States
Rockwood Clinic
Spokane, Washington, United States
MultiCare Allenmore Hospital
Tacoma, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Northwest NCI Community Oncology Research Program
Tacoma, Washington, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Compass Oncology Vancouver
Vancouver, Washington, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, United States
West Virginia University Charleston Division
Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Fox Valley Hematology and Oncology SC-Appleton
Appleton, Wisconsin, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States
Aurora Cancer Care-Franklin
Franklin, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Glendale
Glendale, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, United States
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Diagnostic and Treatment Center
Weston, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2011-02603
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000684313
Identifier Type: -
Identifier Source: secondary_id
CALGB 90802
Identifier Type: OTHER
Identifier Source: secondary_id
CALGB-90802
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02603
Identifier Type: -
Identifier Source: org_study_id
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