Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer
This trial is active, not recruiting.
|Treatments||cisplatin, gemcitabine hydrochloride, paclitaxel|
|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|
|Dijon, France||Hopital Drevon||no longer recruiting|
|Grenoble, France||CHR de Grenoble - La Tronche||no longer recruiting|
|Levallois-Perret, France||Hopital Perpetuel Secours||no longer recruiting|
|Marseille, France||CHU de la Timone||no longer recruiting|
|Metz, France||Hopital Notre-Dame de Bon Secours||no longer recruiting|
|Paris, France||Hopital Laennec||no longer recruiting|
|Paris, France||Hopital Saint Antoine||no longer recruiting|
|Paris, France||Hopital Tenon||no longer recruiting|
|Reims, France||Polyclinique De Courlancy||no longer recruiting|
|Senlis, France||C.H. Senlis||no longer recruiting|
|Thionville, France||Centre Hospitalier Regional Metz Thionville||no longer recruiting|
|Monte Carlo, Monaco||Centre Hospitalier Princesse Grace||no longer recruiting|
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
|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.|
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