Clinical trial NCT00006118: Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer
Official title: First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: stage III bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Hopital Drevon
city: Grenoble
country: France
facility: CHR de Grenoble - La Tronche
city: Levallois-Perret
country: France
facility: Hopital Perpetuel Secours
city: Marseille
country: France
facility: CHU de la Timone
city: Metz
country: France
facility: Hopital Notre-Dame de Bon Secours
city: Paris
country: France
facility: Hopital Laennec
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Tenon
city: Reims
country: France
facility: Polyclinique De Courlancy
city: Senlis
country: France
facility: C.H. Senlis
city: Thionville
country: France
facility: Centre Hospitalier Regional Metz Thionville
city: Monte Carlo
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
affiliation: Hopital Tenon
name: Catherine Maulard-Durdux, MD
role: STUDY_CHAIR
References: