A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients Who Are Ineligible to Receive Cisplatin-Based Therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Median Progression-free Survival (PFS) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria in Participants With Advanced Transitional Cell Carcinoma (TCC) of the Urothelium

Outcome Description:

PFS survival is defined as the time between randomization and the date of progression or death, whichever occurs first, before or after treatment discontinuation. For those still on study and those who remain alive and have not progressed after treatment discontinuation, PFS will be censored on the date of the last tumor assessment.

Outcome Time Frame:

Until tumor progression, unacceptable toxicity, withdrawal of patient consent, or discontinuation by investigator decision

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA183-002

NCT ID:

NCT00389155

Start Date:

January 2007

Completion Date:

January 2008

Related Keywords:

• Bladder Cancer
• Transitional Cell Carcinoma
• Metastasis
• Advanced or metastatic transitional cell carcinoma of the urothelium
• Urinary Bladder Neoplasms
• Carcinoma
• Carcinoma, Transitional Cell
• Neoplasm Metastasis