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

Phase 3

Completed

• Conditions: Transitional Cell Carcinoma of the Urothelial Tract; Bladder Cancer; Bladder Neoplasms
• Interventions: Drug: vinflunine and best supportive care

• Registration Number: NCT00315237
• Lead Sponsor: Pierre Fabre Medicament

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2006-04-14
• Study First Submitted QC: 2006-04-17
• Study First Posted: 2006-04-18
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-06
• Last Update Posted: 2010-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	vinflunine and best supportive care	-

Primary Outcome Measures

Name	Time	Method
duration of Overall Survival after Randomization	30-March-07

Secondary Outcome Measures

Name	Time	Method
patient benefit	30-Mar-07
safety	30-Mar-2007
response rate	throughout the study
time to response	upon occurrence
response duration	throughout the study
progression free survival	throughout the study

Trial Locations

Locations (1)

Local Institution; 🇨🇦 Montreal, Quebec, Canada