Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed locally recurrent or metastatic renal cell carcinoma that is not amenable to resection Progressive disease, defined by 1 of the following: The appearance of 1 or more new lesions At least a 20% increase in the sum of the longest diameters of the target lesions (taking as a reference the smallest sum of the longest diameters recorded since the baseline measurements) (measurable disease stratum closed to accrual as of 7/16/04.) One of the following disease characteristics: Disease manifested solely by bone metastases At least 1 measurable lesion (measurable disease stratum closed to accrual as of 7/16/04.) At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No prior or concurrent brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm^3 OR Absolute neutrophil count greater than 1,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 1.5 mg/dL AST and/or ALT less than 1.5 times upper limit of normal (ULN) Renal: Creatinine less than 1.5 times ULN Cardiovascular: No history of New York Heart Association class II-IV heart disease Pulmonary: No significant pulmonary disease requiring pulse steroid therapy within the past 3 months Other: No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No other serious concurrent medical illness that would preclude study participation No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy/immunotherapy and recovered No more than 1 prior regimen* of biologic therapy/immunotherapy (e.g., interleukin-2, interferon, thalidomide, or combination) Prior sargramostim (GM-CSF) is not counted as prior biological therapy NOTE: *A regimen is considered to be at least 4 weeks of treatment Chemotherapy: No prior chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal agents (e.g., megestrol or tamoxifen) and recovered Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Prior radiotherapy for local control or palliation of painful bony lesion allowed No prior radiotherapy to target lesions No concurrent radiotherapy for palliation or any other indication Surgery: At least 4 weeks since prior surgery and recovered Prior nephrectomy allowed Other: Prior bisphosphonates allowed
Sites / Locations
- Mayo Clinic Scottsdale
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program, Incorporated
- Swedish Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- St. Mary-Corwin Regional Medical Center
- North Suburban Medical Center
- Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
- Mayo Clinic - Jacksonville
- Lakeland Regional Cancer Center at Lakeland Regional Medical Center
- Northeast Georgia Cancer Care, LLC
- Veterans Affairs Medical Center - Augusta
- MBCCOP-Medical College of Georgia Cancer Center
- Medical Center of Central Georgia
- Rush-Copley Cancer Care Center
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Hematology and Oncology Associates
- Veterans Affairs Medical Center - Lakeside Chicago
- University of Illinois Cancer Center
- Veterans Affairs Medical Center - Chicago Westside Hospital
- Mercy Hospital and Medical Center
- Swedish Covenant Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Elmhurst Memorial Hospital
- Hinsdale Hematology Oncology Associates
- Midwest Center for Hematology/Oncology
- Joliet Oncology-Hematology Associates, Limited - West
- North Shore Oncology and Hematology Associates, Limited - Libertyville
- Trinity Medical Center - East
- Northwest Medical Specialist, PC
- Swedish-American Regional Cancer Center
- Hematology Oncology Associates - Skokie
- Hematology/Oncology of the North Shore at Gross Point Medical Center
- Midwest Cancer Research Group, Incorporated
- Regional Cancer Center at Memorial Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Elkhart General Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Saint Anthony Memorial Health Centers
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- McFarland Clinic, P. C.
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- Siouxland Hematology-Oncology Associates
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Pennington Cancer Center at Baton Rouge General
- Mary Bird Perkins Cancer Center - Baton Rouge
- MBCCOP - LSU Health Sciences Center
- Medical Center of Louisiana - New Orleans
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Beth Israel Deaconess Medical Center
- Hickman Cancer Center at Bixby Medical Center
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
- CCOP - Michigan Cancer Research Consortium
- Genesys Hurley Cancer Institute
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Seton Cancer Institute - Saginaw
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- St. John Macomb Hospital
- MeritCare Clinic - Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- CCOP - Duluth
- Miller-Dwan Medical Center
- St. Mary's - Duluth Clinic Cancer Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- HealthEast Cancer Care at St. John's Hospital
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Health Services
- Regions Hospital Cancer Care Center
- St. Joseph's Hospital
- United Hospital
- Saint Francis Cancer Center
- Ridgeview Medical Center
- Bryan LGH Medical Center West
- Cancer Resource Center - Lincoln
- St. Elizabeth Regional Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
- Cancer Institute of New Jersey at Hamilton
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- Stony Brook University Cancer Center
- CCOP - MeritCare Hospital
- MeritCare Medical Group
- Akron City Hospital
- Wood County Oncology Center
- Mercy Cancer Center at Mercy Medical Center
- Aultman Hospital Cancer Center at Aultman Health Foundation
- Adena Regional Medical Center
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Riverside Cancer Services
- Mount Carmel West Hospital
- Doctors Hospital at Ohio Health
- Grady Memorial Hospital
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- Fairfield Medical Center
- Lima Memorial Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- St. Luke's Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- St. Charles Mercy Hospital
- Firelands Regional Medical Center
- Mercy Medical Center
- Community Hospital of Springfield and Clark County
- Promedica Cancer Center at Flower Hospital
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- Fulton County Health Center
- Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
- Genesis - Good Samaritan Hospital
- St. Luke's Hospital Cancer Center
- Geisinger Medical Center
- PinnacleHealth Regional Cancer Center at Polyclinic Hospital
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Central Pennsylvania Hematology and Medical Oncology Associates, P. C.
- Lewistown Hospital
- Joan Karnell Cancer Center at Pennsylvania Hospital
- Reading Hospital and Medical Center
- Guthrie Medical Center - Sayre
- Geisinger Medical Group
- Mount Nittany Medical Center
- Chester County Hospital
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- York Cancer Center at Wellspan Health
- Cancer Care Institute of Carolina at Aiken Regional Medical Centers
- Avera Cancer Institute
- Sioux Valley Hospital and University of South Dakota Medical Center
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
- Green Bay Oncology, Limited at St. Vincent Hospital
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- Dean Medical Center - Fish Hatchery
- Bay Area Cancer Care Center at Bay Area Medical Center
- Marshfield Clinic - Marshfield Center
- All Saints Cancer Center at All Saints Medical Center