A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Median Progression-free Survival (PFS) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria in Participants With Advanced Transitional Cell Carcinoma (TCC) of the Urothelium
PFS survival is defined as the time between randomization and the date of progression or death, whichever occurs first, before or after treatment discontinuation. For those still on study and those who remain alive and have not progressed after treatment discontinuation, PFS will be censored on the date of the last tumor assessment.
Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA183-002
NCT00389155
January 2007
January 2008
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Glendale Memorial Hospital and Health Center | Glendale, California 91204 |
Stanford University | Stanford, California 94305 |
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Medical College of Georgia | Augusta, Georgia 30912 |
Tower Hematology Oncology Medical Group | Los Angeles, California 90048 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
University of Rochester | Rochester, New York 14642 |
Northern Utah Associates | Ogden, Utah 84403 |
Albert Einstein Cancer Center | Bronx, New York 10461 |
Cleveland Clinic | Cleveland, Ohio 44195 |
Lakeland Regional Cancer Center | Lakeland, Florida 33805 |
Charleston Cancer Center | Charleston, South Carolina 29406 |
University of Chicago | Chicago, Illinois 60637 |
Local Institution | Green Bay, Wisconsin |
ACRC/Arizona Clinical Research Center, Inc. | Tucson, Arizona 85712 |
North Valley Hematology/Oncology Medical Group | Northridge, California 91328 |
University of Miami | Miami, Florida 33136 |
Local Institution | Corona, California |
Local Institution | Fort Lauderdale, Florida |
Local Institution | Duluth, Minnesota |
The Center for Cancer and Blood Disorders | Fort Worth, Texas 76104 |
New York Presbyterian Hospital | New York, New York 10021 |
Cancer Specialists of South Texas, PA | Corpus Christi, Texas 78412 |
The West Clinic | Memphis, Tennessee 38120 |
The Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
Nevada Cancer Institute | Las Vegas, Nevada 89135 |
Guthrie Foundation for Education and Research | Sayre, Pennsylvania 18840 |
Kansas City Veterans Affairs Medical Center | Kansas City, Missouri 64128 |
Billings Clinic | Billings, Montana 59107-7000 |
Columbia University Medical Center | New York, New York 10032 |
West Virginia University | Morgantown, West Virginia 26506 |
Nevada Cancer Centers | Las Vegas, Nevada 89109 |
The Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Abramson Cancer Center of the | Philadelphia, Pennsylvania 19104-4283 |
Springfield Clinic, LLP | Springfield, Illinois 62703 |
Mitchell Folbe, MD, PC | Troy, Michigan 48085 |
The Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Cancer Outreach Associates, PC | Abingdon, Virginia 24211 |
South Texas Oncology and Hematology, P.A. | San Antonio, Texas 78207 |
Local Institution | Newark, Delaware |
Central Georgia Cancer Care, PC | Macon, Georgia 31201 |
Advanced Medical Specialties | Miami, Florida 33176 |
Hematology Oncology Centers of the Northern Rockies, PC | Billings, Montana 59101 |
Carolinas Hematology Oncology Associates | Charlotte, North Carolina 28203 |
University Of Florida College Of Medicine At Jacksonville | Jacksonville, Florida 32209 |
Michiana Hematology Oncology, P.C. | South Bend, Indiana 46601 |
University Of Missouri Healthcare/Ellis Fischel Cancer Ctr | Columbia, Missouri 65203 |
Capital Comprehensive Cancer Care Center | Jefferson City, Missouri 65109 |
Mid-Ohio Oncology/Hematology, Inc. Dba | Columbus, Ohio 43219 |
The Jones Clinic, Pc | Germantown, Tennessee 38138 |
Lone Star Oncology Consulants, Pa | Austin, Texas 78759 |
University Of Texas Medical Branch Of Galveston | Galveston, Texas 77555 |
Univ. Of Washington Medical Ctr., Prostate-Oncology Ctr | Seattle, Washington 98195 |