Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency
OBJECTIVES:
- Determine the response rate of patients with progressive regional or metastatic
transitional cell carcinoma of the urothelium with renal insufficiency when treated
with paclitaxel and gemcitabine.
- Determine the toxicity of this regimen in this patient population.
OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV
over 30 minutes on days 1, 8, and 15. Treatment continues every 4 weeks for a minimum of 3
courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for this study within 10-27
months.
Interventional
Primary Purpose: Treatment
David J. Vaughn, MD
Study Chair
Abramson Cancer Center of the University of Pennsylvania
United States: Federal Government
CDR0000067810
NCT00005644
May 2000
Name | Location |
---|---|
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
James P. Wilmot Cancer Center | Rochester, New York 14642 |
Albert Einstein Clinical Cancer Center | Bronx, New York 10461 |