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

July 23, 2008 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Hopital Drevon
      • Grenoble, France, 38043
        • Chr De Grenoble - La Tronche
      • Levallois-Perret, France, 92300
        • Hopital Perpetuel Secours
      • Marseille, France, 13385
        • CHU de la Timone
      • Metz, France, 57038
        • Hopital Notre-Dame de Bon Secours
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75571
        • Hôpital Saint Antoine
      • Paris, France, 75007
        • Hôpital Laënnec
      • Reims, France, F-51100
        • Polyclinique de Courlancy
      • Senlis, France, 60309
        • C.H. Senlis
      • Thionville, France, 57126
        • Centre Hospitalier Regional Metz Thionville
  • Monaco
      • Monte Carlo, Monaco, 98000
        • Centre Hospitalier Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Study Chair: Catherine Maulard-Durdux, MD, Hôpital Tenon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

November 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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