Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer
Recruitment status was Active, not recruiting
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Hopital Drevon | |
| 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 | |
| Hopital Laennec | |
| Paris, France, 75007 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Centre Hospitalier Regional Metz Thionville | |
| Thionville, France, 57126 | |
| Monaco | |
| Centre Hospitalier Princesse Grace | |
| Monte Carlo, Monaco, 98000 | |
| Study Chair: | Catherine Maulard-Durdux, MD | Hopital Tenon |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006118 History of Changes |
| Other Study ID Numbers: | CDR0000068131, FRE-GERCOR-U99-1, EU-20030 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Gemcitabine Cisplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013