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
Not Enrolling
Both
Transitional Cell Carcinoma of the Urothelial Tract, Bladder Cancer, Bladder Neoplasms

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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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