NCT00006118

Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer

First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 combining cisplatin, paclitaxel, and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer.

Detailed description

OBJECTIVES: * Determine the efficacy and toxicity of cisplatin, paclitaxel, and gemcitabine in patients with progressive unresectable regional or metastatic transitional cell carcinoma of the bladder. * Determine the progression free survival of these patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses. Patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 18 months.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	gemcitabine hydrochloride
DRUG	paclitaxel

Timeline

• Start date: 1999-07-01
• First posted: 2003-01-27
• Last updated: 2008-07-24

Locations

12 sites across 2 countries: France, Monaco