Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating patients who have progressive regional or metastatic bladder cancer.
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: docetaxel Drug: gemcitabine hydrochloride||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium|
|Study Start Date:||December 1999|
|Primary Completion Date:||October 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004223
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|Study Chair:||Robert Dreicer, MD, FACP||The Cleveland Clinic|