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

Tracking Information

First Received Date ^ICMJE

August 3, 2000

Last Updated Date

July 23, 2008

Start Date ^ICMJE

July 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00006118 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Bladder Cancer

Intervention ^ICMJE

Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France, Monaco

Administrative Information

NCT ID ^ICMJE

NCT00006118

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068131, FRE-GERCOR-U99-1, EU-20030

Study Sponsor ^ICMJE

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Catherine Maulard-Durdux, MD

Hopital Tenon

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP