Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

February 27, 2010 updated by: Bristol-Myers Squibb

A Phase II Study of Intravenous (IV) Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma (TCC) of the Urothelium

The purpose of this clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. The safety of this treatment will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

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

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia
        • Local Institution
      • Sydney, New South Wales, Australia
        • Local Institution
      • Taree, New South Wales, Australia
        • Local Institution
      • Waratah, New South Wales, Australia
        • Local Institution
      • Westmead, New South Wales, Australia
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia
        • Local Institution
  • Austria
      • Linz, Austria
        • Local Institution
      • Salzburg, Austria
        • Local Institution
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Local Institution
    • Ontario
      • London, Ontario, Canada
        • Local Institution
      • Toronto, Ontario, Canada
        • Local Insitution
    • Quebec
      • Montreal, Quebec, Canada
        • Local Institution
  • France
      • Caen, France
        • Local Institution
      • Le Mans Cedex 2, France
        • Local Institution
      • Nice, France
        • Local Institution
      • Paris, France
        • Local Institution
      • Toulouse, France
        • Local Institution
  • Greece
      • Ilion, Greece
        • Local Institution
  • Indonesia
      • Jakarta, Indonesia
        • Local Institution
  • Italy
      • Genova, Italy
        • Local Institution
      • Milan, Italy
        • Local Institution
      • Roma, Italy
        • Local Institution
      • Rome, Italy
        • Local Institution
      • Viterbo, Italy
        • Local Institution
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Local Institution
  • Philippines
      • Cebu City, Philippines
        • Local Institution
      • Quezon, Philippines
        • Local Institution
      • Quezon City, Philippines
        • Local Institution
  • Singapore
      • Singapore, Singapore
        • Local Institution
  • Spain
      • Murcia, Spain
        • Local Institution
      • Palma De Mallorca, Spain
        • Local Institution
      • Santander, Spain
        • Local Institution
      • Sevilla, Spain
        • Local Institution
  • Sweden
      • Linkoping, Sweden
        • Local Institution
      • Uppsala, Sweden
        • Local Institution
  • Switzerland
      • Aarau, Switzerland
        • Local Institution
  • Thailand
      • Bangkok, Thailand
        • Local Institution
  • United States
    • California
      • Beverly Hills, California, United States
        • Local Institution
      • La Jolla, California, United States
        • Local Institution
      • Los Angeles, California, United States
        • Local Institution
      • Santa Monica, California, United States
        • Local Institution
      • Stanford, California, United States
        • Local Institution
      • Vallejo, California, United States
        • Local Institution
    • Colorado
      • Aurora, Colorado, United States
        • Local Institution
    • Connecticut
      • New Haven, Connecticut, United States
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States
        • Local Institution
    • Florida
      • Jacksonville, Florida, United States
        • Local Institution
      • Miami, Florida, United States
        • Local Institution
    • Georgia
      • Atlanta, Georgia, United States
        • Local Institution
    • Hawaii
      • Honolulu, Hawaii, United States
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States
        • Local Institution
      • Joliet, Illinois, United States
        • Local Institution
      • Urbana, Illinois, United States
        • Local Institution
    • Kentucky
      • Louisville, Kentucky, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
    • Massachusetts
      • Burlington, Massachusetts, United States
        • Local Institution
    • Michigan
      • Ann Arbor, Michigan, United States
        • Local Institution
      • Detroit, Michigan, United States
        • Local Institution
    • Missouri
      • Kansas City, Missouri, United States
        • Local Institution
      • St. Louis, Missouri, United States
        • Local Institution
    • Nevada
      • Las Vegas, Nevada, United States
        • Local Institution
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Local Institution
    • New York
      • Bronx, New York, United States
        • Local Institution
      • Buffalo, New York, United States
        • Local Institution
      • New York, New York, United States
        • Local Institution
    • North Carolina
      • Charlotte, North Carolina, United States
        • Local Institution
      • Durham, North Carolina, United States
        • Local Institution
    • Ohio
      • Cincinnati, Ohio, United States
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Local Institution
      • Pittsburgh, Pennsylvania, United States
        • Local Institution
    • Rhode Island
      • Providence, Rhode Island, United States
        • Local Institution
    • Tennessee
      • Nashville, Tennessee, United States
        • Local Institution
    • Texas
      • Dallas, Texas, United States
        • Local Institution
    • Washington
      • Seattle, Washington, United States
        • Local Institution
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • 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:

  • Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic (i.e. patients cannot be candidates for local/regional control of disease).
  • Relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemotherapy regimen.
  • Adequate performance status (Karnofsky greater or equal to 80).

Exclusion Criteria:

  • Receipt of more than 1 prior chemotherapy regimen in any setting.
  • Prior discontinuation of platinum due solely to toxicity.
  • Current neuropathy greater or equal to CTC grade 2.
  • Prior radiation to greater or equal to 30% of bone marrow.
  • Inadequate hematologic function: ANC <1,500 cells/mm3, Platelet<100,000 cells/mm3.
  • Inadequate hepatic function: total bilirubin > 1.5 times ULN, ALT/AST > 2.5 times ULN or > 5 times ULN in case of liver metastasis.
  • Inadequate renal function: creatinine clearance <20 ml/min.
  • Prior allergy to any vinca-alkaloid.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: vinflunine
solution for injection, IV, 280/320 mg/m2, every 3 wks, variable duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To estimate the objective response rate in patients with TCC of the urothelium receiving vinflunine, who had evidence of documented progression at any time within 12 months after the last dose of platinum therapy and are not candidates of cystectomy.
Time Frame: 10-Apr-2007
10-Apr-2007

Secondary Outcome Measures

Outcome Measure
Time Frame
To estimate duration of response, time to response disease control rate, progression free survival, and overall survival in this patient population, and evaluate the safety profile of vinflunine
Time Frame: 10-April-2007
10-April-2007

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Collaborators

Pierre Fabre Medicament

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

January 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 12, 2005

First Submitted That Met QC Criteria

January 12, 2005

First Posted (Estimate)

January 13, 2005

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 27, 2010

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA183-001

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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