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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315237
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : January 7, 2010
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Transitional Cell Carcinoma of the Urothelial Tract Bladder Cancer Bladder Neoplasms Drug: vinflunine and best supportive care Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. duration of Overall Survival after Randomization [ Time Frame: 30-March-07 ]

Secondary Outcome Measures :
  1. patient benefit [ Time Frame: 30-Mar-07 ]
  2. safety [ Time Frame: 30-Mar-2007 ]
  3. response rate [ Time Frame: throughout the study ]
  4. time to response [ Time Frame: upon occurrence ]
  5. response duration [ Time Frame: throughout the study ]
  6. progression free survival [ Time Frame: throughout the study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00315237

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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
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00315237    
Other Study ID Numbers: L0070 IN 302 P1
First Posted: April 18, 2006    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action