Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract

January 6, 2010 updated by: Pierre Fabre Medicament

Prospective, Randomized Phase III Trial of I.V. Vinflunine Plus Best Supportive Care as Second Line Therapy Versus Best Supportive Care After a Platinum-containing Regimen, in Patients With Advanced Transitional Cell Carcinoma of Urothelial Tract

The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

364

Phase

  • Phase 3

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Local Institution
      • Edmonton, Alberta, Canada
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Local Institution
      • Victoria, British Columbia, Canada
        • Local Institution
    • Ontario
      • Brampton, Ontario, Canada
        • Local Institution
      • Hamilton, Ontario, Canada
        • Local Institution
      • Kingston, Ontario, Canada
        • Local Institution
      • London, Ontario, Canada
        • Local Institution
      • Toronto, Ontario, Canada
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada
        • Local Institution

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bladder cancer
  • Progressed after 1st line platinum-chemotherapy
  • >= 18 years old
  • Adequate hematologic, hepatic & renal function

Exclusion Criteria:

  • CNS disease
  • Moderate neuropathy
  • More than 1 previous chemotherapy

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
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: vinflunine and best supportive care
solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration
No Intervention: 2
best supportive care for 18 week duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration of Overall Survival after Randomization
Time Frame: 30-March-07
30-March-07

Secondary Outcome Measures

Outcome Measure
Time Frame
patient benefit
Time Frame: 30-Mar-07
30-Mar-07
safety
Time Frame: 30-Mar-2007
30-Mar-2007
response rate
Time Frame: throughout the study
throughout the study
time to response
Time Frame: upon occurrence
upon occurrence
response duration
Time Frame: throughout the study
throughout the study
progression free survival
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

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

Sponsor

Pierre Fabre Medicament

Collaborators

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

April 14, 2006

First Submitted That Met QC Criteria

April 17, 2006

First Posted (Estimate)

April 18, 2006

Study Record Updates

Last Update Posted (Estimate)

January 7, 2010

Last Update Submitted That Met QC Criteria

January 6, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L0070 IN 302 P1
  • CA183004

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.

Clinical Trials on Bladder Cancer

Clinical Trials on vinflunine and best supportive care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe