First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine
18 Years
75 Years
Both
Bladder Cancer
Trial Information
First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Catherine Maulard-Durdux, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Tenon
Authority:
United States: Federal Government
Study ID:
CDR0000068131
NCT ID:
NCT00006118
Start Date:
July 1999
Completion Date:
Related Keywords:
- Bladder Cancer
- stage III bladder cancer
- stage IV bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
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