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First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy
Not Recruiting
Trial ID: NCT00389155
Purpose
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.
Official Title
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
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
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:
- 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
Exclusion Criteria:
- Patients in whom radiation or surgery is indicated
- Current neuropathy ≥ CTCAE grade 3
- Prior radiation to ≥ 30% of bone marrow
- Inadequate renal function: serum creatinine clearance ≤ 20 mL/min
- Prior allergy to any vinca alkaloid
Intervention(s):
drug: Vinflunine
drug: Gemcitabine
other: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Denise Haas
6507361252