Bladder Cancer Clinical Trial
Official title:
Phase II Study on SCH 66336 (Farnesyl Protein Transferase Inhibitor) and Gemcitabine as Second Line Treatment in Advanced Metastatic Urothelial Cancer - EORTC Study 16997
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining SCH 66336 and gemcitabine may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine in treating
patients who have advanced cancer of the urinary tract.
OBJECTIVES:
- 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
unacceptable toxicity.
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
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