Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II

Inclusion Criteria

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)