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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Vinflunine
- drug : Gemcitabine
- other : Placebo
Phase: Phase 2/Phase 3
Ages Eligible For Study:
- 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: - Calculated creatinine clearance ?60 mL/min: OR - New York Heart Association Classification Stage III-IV Congestive Heart Failure - 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