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

Phase 2

• Conditions: Bladder Cancer

• Registration Number: NCT00006118
• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Brief 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.

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 2000-08-03
• Status Verified: 2001-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Last Update Submitted: 2008-07-23
• Last Update Posted: 2008-07-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (12)

CHR de Grenoble - La Tronche; 🇫🇷 Grenoble, France

C.H. Senlis; 🇫🇷 Senlis, France

Centre Hospitalier Regional Metz Thionville; 🇫🇷 Thionville, France

Hopital Tenon; 🇫🇷 Paris, France

CHU de la Timone; 🇫🇷 Marseille, France

Polyclinique De Courlancy; 🇫🇷 Reims, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Hopital Perpetuel Secours; 🇫🇷 Levallois-Perret, France

Hopital Drevon; 🇫🇷 Dijon, France

Hopital Laennec; 🇫🇷 Paris, France

Hopital Notre-Dame de Bon Secours; 🇫🇷 Metz, France

Centre Hospitalier Princesse Grace; 🇲🇨 Monte Carlo, Monaco