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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Transitional Cell Carcinoma of the Urothelial Tract, Bladder Cancer, Bladder Neoplasms
Both
Transitional Cell Carcinoma of the Urothelial Tract, Bladder Cancer, Bladder Neoplasms
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
duration of Overall Survival after Randomization
Outcome Time Frame:
30-March-07
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Canada: Health Canada
Study ID:
L0070 IN 302 P1
NCT ID:
NCT00315237
Start Date:
July 2005
Completion Date:
January 2008
Related Keywords:
- Transitional Cell Carcinoma of the Urothelial Tract
- Bladder Cancer
- Bladder Neoplasms
- Urinary Bladder Neoplasms
- Neoplasms
- Carcinoma
- Carcinoma, Transitional Cell
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