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

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra) not curable by surgery or radiotherapy
• * Any T, N0-3, M1 or unresectable M0
• * Poorly differentiated TCC, predominant TCC with rare foci of squamous differentiation, or rare foci of adenocarcinoma allowed
• Measurable disease
• * At least 1 lesion accessible for biopsy
• * Soft tissue disease that has been irradiated within the past 2 months not considered measurable disease
• Progressive or recurrent disease after only 1 prior systemic chemotherapy regimen for advanced disease
• No adenocarcinoma, small cell carcinoma, sarcoma, squamous cell carcinoma, or mixed histology
• PATIENT CHARACTERISTICS:
• Age:
• Any age
• Performance status:
• Zubrod 0-2
• Life expectancy:
• Not specified
• Hematopoietic:
• Platelet count at least 100,000/mm3
• Absolute granulocyte count at least 1,200/mm3
• Hepatic:
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2 times ULN
• Renal:
• Creatinine no greater than 2 times ULN
• Other:
• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• Not pregnant or nursing
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No concurrent filgrastim (G-CSF)
• Chemotherapy:
• See Disease Characteristics
• No prior adjuvant chemotherapy
• At least 28 days since prior chemotherapy and recovered
• Endocrine therapy:
• Not specified
• Radiotherapy:
• See Disease Characteristics
• At least 28 days since prior radiotherapy and recovered
• Surgery:
• See Disease Characteristics
• At least 28 days since prior surgery and recovered
• Other:
• No prior systemic therapy between biopsy and study entry
• At least 28 days since prior intravesical therapy and recovered
• No concurrent agents that induce CYP3A4 (e.g., nafcillin, rifampin, carbamazepine, phenobarbital, phenytoin, or St. John's Wort)