This trial is active, not recruiting.

Condition bladder cancer
Treatments cisplatin, gemcitabine hydrochloride, paclitaxel
Phase phase 2
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date July 1999
Trial identifier NCT00006118, CDR0000068131, EU-20030, FRE-GERCOR-U99-1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).