Spots Global Cancer Trial Database for Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
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Trial Identification
Brief Title: Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
Official Title: Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium
Study ID: NCT00004223
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating patients who have progressive regional or metastatic bladder cancer.
Detailed Description: OBJECTIVES: I. Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium and failure of only 1 prior systemic regimen treated with docetaxel and gemcitabine. II. Determine the toxicities of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1 and 8. For patients with complete or partial response or stable disease at 3 weeks, treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until disease progression. PROJECTED ACCRUAL: A total of 22-45 patients will be accrued for this study over 18-21 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States
Cancer Center and Beckman Research Institute, City of Hope, Duarte, California, United States
Veterans Affairs Medical Center - Palo Alto, Palo Alto, California, United States
Stanford University Medical Center, Stanford, California, United States
CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado, United States
CCOP - Christiana Care Health Services, Wilmington, Delaware, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Veterans Affairs Medical Center - Gainsville, Gainesville, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, United States
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Veterans Affairs Medical Center - Lakeside Chicago, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
Trinitas Hospital - Jersey Street Campus, Elizabeth, New Jersey, United States
Hunterdon Regional Cancer Center, Flemington, New Jersey, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Kimball Medical Center, Lakewood, New Jersey, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County, Mount Holly, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Riverview Medical Center - Booker Cancer Center, Red Bank, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
Veterans Affairs Medical Center - Albany, Albany, New York, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York, United States
Veterans Affairs Medical Center - New York, New York, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
University of Rochester Cancer Center, Rochester, New York, United States
CCOP - Merit Care Hospital, Fargo, North Dakota, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Veterans Affairs Medical Center - Cleveland, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio, United States
CCOP - Sooner State, Tulsa, Oklahoma, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
Hahnemann University Hospital, Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
Veterans Affairs Medical Center - Nashville, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, United States
MBCCOP - San Juan, San Juan, , Puerto Rico
Veterans Affairs Medical Center - San Juan, San Juan, , Puerto Rico
Pretoria Academic Hospitals, Pretoria, , South Africa
Contact Details
Name: Robert Dreicer, MD, FACP
Affiliation: The Cleveland Clinic
Role: STUDY_CHAIR
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