Phase II Study on SCH 66336 (Farnesyl Protein Transferase Inhibitor) and Gemcitabine as Second Line Treatment in Advanced Metastatic Urothelial Cancer - EORTC Study 16997
- Determine the feasibility and toxicity of SCH 66336 and gemcitabine in patients with
advanced transitional cell carcinoma of the urinary tract.
- Determine the time to progression and objective response rate of this treatment regimen
in these patients.
- Assess the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral SCH 66336
twice a day (starting on day 2 of the first course, and starting on day 1 of all subsequent
courses). Treatment repeats every 28 days in the absence of disease progression or
Patients are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 7-31 patients will be accrued for this study.
Primary Purpose: Treatment
Ronald De Wit, MD, PhD
Daniel Den Hoed Cancer Center at Erasmus Medical Center
United States: Federal Government