Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer
NCT ID: NCT00006118
Last Updated: 2008-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
1999-07-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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cisplatin
gemcitabine hydrochloride
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Principal Investigators
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Catherine Maulard-Durdux, MD
Role: STUDY_CHAIR
Hopital Tenon
Locations
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Hopital Drevon
Dijon, , France
CHR de Grenoble - La Tronche
Grenoble, , France
Hopital Perpetuel Secours
Levallois-Perret, , France
CHU de la Timone
Marseille, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
Hopital Laennec
Paris, , France
Hopital Saint Antoine
Paris, , France
Hopital Tenon
Paris, , France
Polyclinique De Courlancy
Reims, , France
C.H. Senlis
Senlis, , France
Centre Hospitalier Regional Metz Thionville
Thionville, , France
Centre Hospitalier Princesse Grace
Monte Carlo, , Monaco
Countries
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Other Identifiers
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FRE-GERCOR-U99-1
Identifier Type: -
Identifier Source: secondary_id
EU-20030
Identifier Type: -
Identifier Source: secondary_id
CDR0000068131
Identifier Type: -
Identifier Source: org_study_id