Evaluation of ZD 1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II

Pts must have histologically confirmed Stage M1 transitional cell carcinoma of the urothelial tract (bladder, renal pelvis, ureter, urethra) not curable by surgery or RT. Stage N+, M0 pts w/unresectable disease are also eligible. At least one lesion must be accessible for biopsy. Pts must have measurable disease. Soft tissue disease which has been radiated in the 2 months prior to registration is not assessable as measurable disease. Pts must have disease that has progressed or recurred following one (and only one) prior systemic chemo regimen for adv disease and at least 28 days must have elapsed since the last chemo tx. No prior adjuvant chemo is allowed. Pts may have had prior intravesical therapy, RT or surgery, but at least 28 days must have elapsed since the most recent therapy. Pts must have an AGC >/= 1,200/ml, PLT >/= 100,000/ml, bilirubin less than/equal 1.5 x IULN, SGOT less than/equal 2 x IULN and creatinine less than/equal 2 x IULN w/in 28 days prior to registration. Pts must have had a biopsy prior to registration and agree to have tissue specimens submitted as outline in Sect 15.0 for immunohistochemistry. Biopsy can be from either the bladder primary or the metastatic site, but pt must not have rec'd any systemic therapy between time of biopsy and registration. Pts must have a Zubrod PS of 0-2. Pts requiring agents that induce CYP3A4 are excluded.