Spots Global Cancer Trial Database for SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract

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Trial Identification

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

Conditions

Bladder Cancer

Transitional Cell Cancer of the Renal Pelvis and Ureter

Urethral Cancer

Interventions

gemcitabine hydrochloride

lonafarnib

Study Description

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.