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Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer

Bladder Cancer Clinical Trial

Official title:
Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004223
Study type Interventional
Source Eastern Cooperative Oncology Group
Contact
Status Completed
Phase Phase 2
Start date February 24, 2000
View Details
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