Spots Global Cancer Trial Database for Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer

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Trial Identification

Brief Title: Combination Chemotherapy Plus Filgrastim in Treating Patients With Locally Recurrent or Advanced Urothelium Cancer

Official Title: Treatment of Patients With Transitional-Cell Carcinoma of the Urothelial Tract With Gemcitabine, Docetaxel and Filgrastim

Study ID: NCT00005958

Conditions

Bladder Cancer

Transitional Cell Cancer of the Renal Pelvis and Ureter

Interventions

filgrastim

docetaxel

gemcitabine hydrochloride

Study Description

Brief Summary: 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.

Detailed Description: 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.