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

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315237
• Other study ID #: L0070 IN 302 P1
• Secondary ID: CA183004
• Status: Completed
• Phase: Phase 3
• First received: April 14, 2006
• Last updated: January 6, 2010
• Start date: July 2005
• Est. completion date: January 2008

Study information

• Verified date: January 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Bladder Neoplasms
• Carcinoma
• Carcinoma, Transitional Cell
• Transitional Cell Carcinoma of the Urothelial Tract
• Urinary Bladder Neoplasms

Intervention

Drug:
• vinflunine and best supportive care
solution for injection, IV, 280/320 mg/m2, every 3 wks variable duration

Locations

Country	Name	City	State
Canada	Local Institution	Brampton	Ontario
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	Kingston	Ontario
Canada	Local Institution	London	Ontario
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Pierre Fabre Medicament	Bristol-Myers Squibb

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of Overall Survival after Randomization		30-March-07	No
Secondary	patient benefit		30-Mar-07	No
Secondary	safety		30-Mar-2007	Yes
Secondary	response rate		throughout the study	No
Secondary	time to response		upon occurrence	No
Secondary	response duration		throughout the study	No
Secondary	progression free survival		throughout the study	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm