S0031, ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of cancer of the urinary tract. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have advanced cancer of the urinary tract.

OBJECTIVES: * Determine the 6-month progression-free survival rate of patients with advanced transitional cell carcinoma of the urothelium treated with ZD 1839. * Determine the overall survival and response (confirmed complete and partial response) in these patients treated with this regimen. * Determine the qualitative and quantitative toxicity of this regimen in these patients. * Evaluate the changes in growth factor protein kinase expression before and after treatment and at the time of disease progression in these patients treated with this regimen. OUTLINE: Patients receive oral ZD 1839 once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.