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

• Sponsor: Pierre Fabre Medicament (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00315237
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 364
• Locations: 10
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 36.4
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Jul 1, 2005
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. duration of Overall Survival after Randomization [30-March-07]

Secondary Outcome Measures

1. patient benefit [30-Mar-07]

2. safety [30-Mar-2007]

3. response rate [throughout the study]

4. time to response [upon occurrence]

5. response duration [throughout the study]

6. progression free survival [throughout the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Calgary	Alberta	Canada
2	Local Institution	Edmonton	Alberta	Canada
3	Local Institution	Vancouver	British Columbia	Canada
4	Local Institution	Victoria	British Columbia	Canada
5	Local Institution	Brampton	Ontario	Canada
6	Local Institution	Hamilton	Ontario	Canada
7	Local Institution	Kingston	Ontario	Canada
8	Local Institution	London	Ontario	Canada
9	Local Institution	Toronto	Ontario	Canada
10	Local Institution	Montreal	Quebec	Canada

Sponsors and Collaborators

• Pierre Fabre Medicament
• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00315237
• Other Study ID Numbers: L0070 IN 302 P1; CA183004
• First Posted: Apr 18, 2006
• Last Update Posted: Jan 7, 2010
• Last Verified: Jan 1, 2010

• Additional relevant MeSH terms: Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Study Results

No Results Posted as of Jan 7, 2010