Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy

Pts must have histologically proven Stage IV locally advanced disease (T4b any N or any T N2-3) or metastatic (M1) transitional cell carcinoma of the urothelium (pure or mixed). Pts should not be suitable for surgery or RT w/curative intent. Pts must have either mx or non-mx (evaluable) disease as defined by RECIST. No prior systemic chemo or inv agents. Loc intravesical chemo or immuno allowed if completed at least 4 wks prior to reg. One course of prior RT allowed if completed at least 4 wks prior to reg. PS WHO 0 or 1. Bili < 1.25 x IULN. SGOT or SGPT < 2.5 x IULN. > 18 yrs and considered fit for cisplatin containing regimens. WBC >/= 3000, PLTS >/= 100,000 and HG >/= 10 g/dl. Estimated life expectancy of at least 12 wks. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance. Adequate renal function - GFR >/= 60 ml/min. Serum Ca w/in normal inst limit. Agree to use appropriate contraception. Pts must not have Grade 3-4 infection w/out neutropenia; known CNS mets; be pregnant or nursing; serious concomitant systemic disorders; prior or concomitant malignancies; Gr 2 or greater peripheral neuropathy or presence of any clinically significant cardiac arrhythmia, CHF or complete bundle brance block functional Class III or worse.