Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT00006118|
Recruitment Status : Unknown
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : July 24, 2008
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 or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine|
|Study Start Date :||July 1999|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006118
|Dijon, France, 21000|
|CHR de Grenoble - La Tronche|
|Grenoble, France, 38043|
|Hopital Perpetuel Secours|
|Levallois-Perret, France, 92300|
|CHU de la Timone|
|Marseille, France, 13385|
|Hopital Notre-Dame de Bon Secours|
|Metz, France, 57038|
|Paris, France, 75007|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75970|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Senlis, France, 60309|
|Centre Hospitalier Regional Metz Thionville|
|Thionville, France, 57126|
|Centre Hospitalier Princesse Grace|
|Monte Carlo, Monaco, 98000|
|Study Chair:||Catherine Maulard-Durdux, MD||Hopital Tenon|