Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (And in a Cohort of Patients Younger Than 60 Years)

Pts must have hist conf urothelial (bladder, renal pelvis, ureter, urethra) cancer. TCC, adeno or squamous okay. Pts must be 70 years or older or less than 60. Pts must have mx disease assessed w/in 28 days prior to reg which meets one of the criteria in Sect 5.3. Non-mx disease must be assessed w/in 42 days prior to reg. Pt must have following labs obtained w/in 28 days prior to reg: creatinine & bili less than IULN, SGOT/SGPT less than/equal 2 X IULN, AGC greater than/equal 1,200 and PLT greater than/equal 100,000. No prior chemo w/the exception of adj chemo administered more than 10 years ago which did not contain taxanes, gemcitabine or platinum complexes. Recovered from effects of surgery or RT and at least 28 days elapsed. PS 0-2. Pt must agree to undergo pharmacokinetic sampling and sample submission for genetic polymorphisms. Pt must be able to read & understand English or Spanish to participate in the QOL portion of the study. Pt must not be pregnant or nursing. Pt must agree to effective contraceptive method. Pt must not be known to be HIV positive. Pt must not suffer from any life-threatening intercurrent medical disorder. No other prior malignancy.