Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium
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.
Interventional
Primary Purpose: Treatment
Robert Dreicer, MD, FACP
Study Chair
The Cleveland Clinic
United States: Food and Drug Administration
CDR0000067464
NCT00004223
December 1999
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Evanston | Evanston, Illinois 60201 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Veterans Affairs Medical Center - New York | New York, New York 10010 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Veterans Affairs Medical Center - Pittsburgh | Pittsburgh, Pennsylvania 15240 |
Trinitas Hospital - Jersey Street Campus | Elizabeth, New Jersey 07201 |
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | Mount Holly, New Jersey 08060 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Hunterdon Regional Cancer Center | Flemington, New Jersey 08822 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
Veterans Affairs Medical Center - Cleveland | Cleveland, Ohio 44106 |
Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |
Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
CCOP - Sooner State | Tulsa, Oklahoma 74136 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Kimball Medical Center | Lakewood, New Jersey 08701 |
Riverview Medical Center - Booker Cancer Center | Red Bank, New Jersey 07701 |
Veterans Affairs Medical Center - Gainsville | Gainesville, Florida 32608-1197 |