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

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)