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.

Condition	Treatment or Intervention	Phase
stage III bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder	Drug: cisplatin  Drug: gemcitabine  Drug: paclitaxel  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven progressive unresectable regional or metastatic transitional cell carcinoma of the bladder
• Measurable disease by CT or MRI scan
• Greater than 10 mm

PATIENT CHARACTERISTICS: Age:

• 18 to 75

Performance status:

• WHO 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 150,000/mm^3

Hepatic:

• Not specified

Renal:

• Creatinine less than 1.36 mg/dL

Cardiovascular:

• No uncontrolled cardiac disease
• No severe cardiac arrhythmias

Other:

• Not pregnant or nursing
• No other prior malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Prior intravesical immunotherapy for superficial disease allowed
• No prior systemic biologic response modifier therapy for advanced disease

Chemotherapy:

• Prior intravesical chemotherapy for superficial disease allowed
• No prior systemic chemotherapy for advanced disease

Endocrine therapy:

• Not specified

Radiotherapy:

• Prior radiotherapy allowed

Surgery:

• No prior surgery

France
      C.H. Senlis, Senlis,  60309,  France
      Centre Hospitalier Regional Metz Thionville, Thionville,  57126,  France
      CHR de Grenoble - La Tronche, Grenoble,  38043,  France
      CHU de la Timone, Marseille,  13385,  France
      Hopital Drevon, Dijon,  21000,  France
      Hopital Laennec, Paris,  75007,  France
      Hopital Notre-Dame de Bon Secours, Metz,  57038,  France
      Hopital Perpetuel Secours, Levallois-Perret,  92300,  France
      Hopital Saint Antoine, Paris,  75571,  France
      Hopital Tenon, Paris,  75970,  France
      Polyclinique De Courlancy, Reims,  F-51100,  France
Monaco
      Centre Hospitalier Princesse Grace, Monte Carlo,  98000,  Monaco

Study chairs or principal investigators

Catherine Durdux, MD,  Study Chair,  Hopital Tenon   

Study ID Numbers:  CDR0000068131; FRE-GERCOR-U99-1; EU-20030
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006118
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08