Bladder Cancer Clinical Trial
Official title:
Treatment of Patients With Transitional-Cell Carcinoma of the Urothelial Tract With Gemcitabine, Docetaxel and Filgrastim
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the
number of immune cells found in bone marrow or peripheral blood and may help a person's
immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with
gemcitabine and docetaxel plus filgrastim in treating patients who have locally recurrent or
advanced urothelium cancer.
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.
;
Primary Purpose: Treatment
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