Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006118 |
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 | Intervention | Phase |
---|---|---|
Bladder Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease by CT or MRI scan
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
France | |
C.H. Senlis | |
Senlis, France, 60309 | |
Centre Hospitalier Regional Metz Thionville | |
Thionville, France, 57126 | |
CHR de Grenoble - La Tronche | |
Grenoble, France, 38043 | |
Hopital Laennec | |
Paris, France, 75007 | |
Hopital Drevon | |
Dijon, France, 21000 | |
CHU de la Timone | |
Marseille, France, 13385 | |
Hopital Notre-Dame de Bon Secours | |
Metz, France, 57038 | |
Hopital Perpetuel Secours | |
Levallois-Perret, France, 92300 | |
Hopital Saint Antoine | |
Paris, France, 75571 | |
Hopital Tenon | |
Paris, France, 75970 | |
Polyclinique De Courlancy | |
Reims, France, F-51100 | |
Monaco | |
Centre Hospitalier Princesse Grace | |
Monte Carlo, Monaco, 98000 |
Study Chair: | Catherine Maulard-Durdux, MD | Hopital Tenon |
Study ID Numbers: | CDR0000068131, FRE-GERCOR-U99-1, EU-20030 |
Study First Received: | August 3, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006118 History of Changes |
Health Authority: | United States: Federal Government |
stage III bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder |
Antimetabolites Urinary Tract Neoplasm Cystocele Immunologic Factors Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Antimitotic Agents Carcinoma, Transitional Cell Urologic Neoplasms Immunosuppressive Agents |
Antiviral Agents Carcinoma Radiation-Sensitizing Agents Cisplatin Urologic Diseases Paclitaxel Tubulin Modulators Bladder Neoplasm Gemcitabine Antineoplastic Agents, Phytogenic Transitional Cell Carcinoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Cisplatin Urologic Diseases Therapeutic Uses Gemcitabine |
Mitosis Modulators Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Antimitotic Agents Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Antineoplastic Agents, Phytogenic |