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Brief Title: SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
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
Study ID: NCT00006351
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Medical Center Nijmegen, Nijmegen, , Netherlands
Name: Ronald De Wit, MD, PhD
Affiliation: Daniel Den Hoed Cancer Center at Erasmus Medical Center
Role: STUDY_CHAIR
Name: Pieter H. M. de Mulder, MD, PhD
Affiliation: Universitair Medisch Centrum St. Radboud - Nijmegen
Role: STUDY_CHAIR
Name: Godefridus Peters, PhD
Affiliation: Free University Medical Center
Role: STUDY_CHAIR