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Brief Title: Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
Official Title: A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma
Study ID: NCT00039429
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer.
Detailed Description: OBJECTIVES: * Determine the 6-month progression-free survival rate, in terms of proportion of those with measurable disease or bone metastases only, of patients with locally recurrent or metastatic renal cell carcinoma treated with atrasentan (measurable disease stratum closed to accrual as of 7/16/04). * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior immunotherapy/biologic therapy (yes vs no) and characteristic of disease (measurable vs bone metastases only) (measurable disease stratum closed to accrual as of 7/16/04). Patients receive oral atrasentan once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 180 patients (90 per stratum \[with or without prior therapy\]) will be accrued for this study within 6 months (based on prior accrual, the bone metastases only group \[specifically patients who have received 1 prior therapy\] is the only stratum open for accrual).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Aurora Presbyterian Hospital, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States
St. Mary-Corwin Regional Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center, Boca Raton, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center, Lakeland, Florida, United States
Northeast Georgia Cancer Care, LLC, Athens, Georgia, United States
Veterans Affairs Medical Center - Augusta, Augusta, Georgia, United States
MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia, United States
Medical Center of Central Georgia, Macon, Georgia, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Hematology and Oncology Associates, Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago Westside Hospital, Chicago, Illinois, United States
Mercy Hospital and Medical Center, Chicago, Illinois, United States
Swedish Covenant Hospital, Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Elmhurst Memorial Hospital, Elmhurst, Illinois, United States
Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, United States
Midwest Center for Hematology/Oncology, Joliet, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West, Joliet, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, United States
Trinity Medical Center - East, Moline, Illinois, United States
Northwest Medical Specialist, PC, Niles, Illinois, United States
Swedish-American Regional Cancer Center, Rockford, Illinois, United States
Hematology Oncology Associates - Skokie, Skokie, Illinois, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center, Skokie, Illinois, United States
Midwest Cancer Research Group, Incorporated, Skokie, Illinois, United States
Regional Cancer Center at Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Saint Joseph Regional Medical Center, South Bend, Indiana, United States
McFarland Clinic, P. C., Ames, Iowa, United States
St. Luke's Hospital, Cedar Rapids, Iowa, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, United States
Mercy Capitol Hospital, Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City, Iowa, United States
Siouxland Hematology-Oncology Associates, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines, West Des Moines, Iowa, United States
Pennington Cancer Center at Baton Rouge General, Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans, New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Seton Cancer Institute - Saginaw, Saginaw, Michigan, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
MeritCare Clinic - Bemidji, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller-Dwan Medical Center, Duluth, Minnesota, United States
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Meeker County Memorial Hospital, Litchfield, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis, Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Health Services, Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center, Saint Paul, Minnesota, United States
St. Joseph's Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Cancer Center, Shakopee, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Bryan LGH Medical Center West, Lincoln, Nebraska, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska, United States
St. Elizabeth Regional Medical Center, Lincoln, Nebraska, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center, Flemington, New Jersey, United States
Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
MeritCare Medical Group, Fargo, North Dakota, United States
Akron City Hospital, Akron, Ohio, United States
Wood County Oncology Center, Bowling Green, Ohio, United States
Mercy Cancer Center at Mercy Medical Center, Canton, Ohio, United States
Aultman Hospital Cancer Center at Aultman Health Foundation, Canton, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Grant Riverside Cancer Services, Columbus, Ohio, United States
Mount Carmel West Hospital, Columbus, Ohio, United States
Doctors Hospital at Ohio Health, Columbus, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Fremont Memorial Hospital, Fremont, Ohio, United States
Fairfield Medical Center, Lancaster, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital, Marietta, Ohio, United States
St. Luke's Hospital, Maumee, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark, Ohio, United States
St. Charles Mercy Hospital, Oregon, Ohio, United States
Firelands Regional Medical Center, Sandusky, Ohio, United States
Mercy Medical Center, Springfield, Ohio, United States
Community Hospital of Springfield and Clark County, Springfield, Ohio, United States
Promedica Cancer Center at Flower Hospital, Sylvania, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
St. Vincent Mercy Medical Center, Toledo, Ohio, United States
Medical University of Ohio Cancer Center, Toledo, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital, Westerville, Ohio, United States
Genesis - Good Samaritan Hospital, Zanesville, Ohio, United States
St. Luke's Hospital Cancer Center, Bethlehem, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
PinnacleHealth Regional Cancer Center at Polyclinic Hospital, Harrisburg, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Central Pennsylvania Hematology and Medical Oncology Associates, P. C., Lemoyne, Pennsylvania, United States
Lewistown Hospital, Lewistown, Pennsylvania, United States
Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center, Reading, Pennsylvania, United States
Guthrie Medical Center - Sayre, Sayre, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Mount Nittany Medical Center, State College, Pennsylvania, United States
Chester County Hospital, West Chester, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
York Cancer Center at Wellspan Health, York, Pennsylvania, United States
Cancer Care Institute of Carolina at Aiken Regional Medical Centers, Aiken, South Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston, West Virginia, United States
Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Dean Medical Center - Fish Hatchery, Madison, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, United States
All Saints Cancer Center at All Saints Medical Center, Racine, Wisconsin, United States
Name: Michael A. Carducci, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR