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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: gemcitabine hydrochloride
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: gemcitabine hydrochloride|nan|
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder