Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006118
• Other study ID #: CDR0000068131
• Secondary ID: FRE-GERCOR-U99-1
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 3, 2000
• Last updated: July 23, 2008
• Start date: July 1999

Study information

• Verified date: November 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• cisplatin

• gemcitabine hydrochloride

• paclitaxel

Locations

Country	Name	City	State
France	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
Monaco	Centre Hospitalier Princesse Grace	Monte Carlo

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Countries where clinical trial is conducted

France,  Monaco,