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
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
The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone.
Inclusion Criteria:
Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic
Ineligible for cisplatin-based therapy because of at least one of the following two medical conditions:
Measurable disease documented by imaging with at least one uni-dimensional lesion
Adequate performance status (ECOG 0, 1, or 2)
Men and women ≥18 years of age
Exclusion Criteria:
Hackensack, New Jersey 07601, United States