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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00315237
First received: April 14, 2006
Last updated: January 6, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Transitional Cell Carcinoma of the Urothelial Tract
Bladder Cancer
Bladder Neoplasms
 Drug: vinflunine and best supportive care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • duration of Overall Survival after Randomization [ Time Frame: 30-March-07 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient benefit [ Time Frame: 30-Mar-07 ] [ Designated as safety issue: No ]
  • safety [ Time Frame: 30-Mar-2007 ] [ Designated as safety issue: Yes ]
  • response rate [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • time to response [ Time Frame: upon occurrence ] [ Designated as safety issue: No ]
  • response duration [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 364
Study Start Date: July 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315237

Locations
Canada, Alberta
Local Institution
Calgary, Alberta, Canada
Local Institution
Edmonton, Alberta, Canada
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Victoria, British Columbia, Canada
Canada, Ontario
Local Institution
Brampton, Ontario, Canada
Local Institution
Hamilton, Ontario, Canada
Local Institution
Kingston, Ontario, Canada
Local Institution
London, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Canada, Quebec
Local Institution
Montreal, Quebec, Canada
Sponsors and Collaborators
Pierre Fabre Medicament
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00315237     History of Changes
Other Study ID Numbers: L0070 IN 302 P1, CA183004
Study First Received: April 14, 2006
Last Updated: January 6, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 22, 2013