Phase II Study of Irinotecan in Patients with Advanced Transitional Cell Carcinoma of the Urothelium

Pts must have histo conf T2-4, N0-3, M1 TCC of the urothelial tract not curable by surgery or RT. Stage T2-4, N+, M0 pts w/unresectable disease are also eligible. Pts must have mx disease. Pts must have disease that progressed or recurred after one and only one cisplatin or carboplatin containing regimen for metastatic disease. Pts must not have rec'd prior tx w/ a topoisomerase I inhibitor such as irinotecan or topotecan. Pts may have rec'd prior RT to the pelvis. Pts must have AGC >/= 1,200; PLT >/= 100,000; bili < 1.5 x IULN, SGOT < 3 x IULN, & CREAT < 2 .x IULN w/in 28 days prior to registration. Pts must have stopped taking St. John's Wort at least 14 days prior to registration & must not be planning to take it while on protocol tx and for 7 days following completion of protocol tx. Pts must not have rec'd phenytoin, phenobarbital, carbamazepine or any other enzyme-inducing anti-convulsant drug w/in 7 days prior to registration. Pt must have a Zubrod PS of 0-2. Pts must have no uncontrolled CNS mets. Pts must not be pregnant or nursing. Pts of reproductive potential must have agreed to use an effective contraceptive method.