Treatment of Patients With Transitional-Cell Carcinoma of the Urothelial Tract With Gemcitabine, Docetaxel and Filgrastim
OBJECTIVES: I. Determine the efficacy of gemcitabine, docetaxel, and filgrastim (G-CSF) in
patients with locally recurrent or advanced transitional cell carcinoma of the urothelial
tract. II. Determine the toxicity of this regimen in these patients. III. Determine the
disease-free and overall survival of this patient population treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (yes vs no). Patients receive gemcitabine IV over 30 minutes on days 1 and 8
and docetaxel IV over 1 hour on day 8. Patients also receive filgrastim (G-CSF)
subcutaneously daily beginning on day 9 and continuing until blood counts recover. Treatment
continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable
toxicity. Patients who respond to treatment may undergo surgery and 6-8 weeks later receive
2 more courses of chemotherapy. Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 23-40 patients who have not received prior chemotherapy and 23
patients who have received prior chemotherapy will be accrued for this study within 2 years.
Interventional
Primary Purpose: Treatment
Jennifer Tam
Study Chair
Amgen
United States: Federal Government
CDR0000067939
NCT00005958
October 1999
Name | Location |
---|---|
Arlington Cancer Center | Arlington, Texas 76012 |
Maine Center for Cancer Medicine and Blood Disorders | Scarborough, Maine 04074 |
University of California San Diego | La Jolla, California 92093 |
Washington Cancer Institute | Washington, District of Columbia 20010 |
Northern Virginia Oncology Group | Fairfax, Virginia 22031 |
Sacramento Center for Hematology and Medical Oncology | Sacramento, California 95819 |
Center for Hematology-Oncology | Boca Raton, Florida 33486 |
Oncology-Hematology Associates of North Illinois, Ltd. | Gurnee, Illinois 60031 |
St. Joseph Medical Center | Towson, Maryland 21204 |
Hematology & Oncology Associates of Southern Michigan | Jackson, Michigan 49201 |
Hematology Oncology Associates of Central New York | Syracuse, New York 13217-6962 |
Memphis Cancer Center, Inc. | Memphis, Tennessee 38119 |