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Spots Global Cancer Trial Database for Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

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Trial Identification

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

Conditions

Kidney Cancer

Study Description

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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Michael A. Carducci, MD

Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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