Phase II Study of Intravesical Gemcitabine in Patients with Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG

Pts must have histologically proven, recurrent superficial TCC of the bladder Stage T1 Grade 2-4; Stage Tis; Stage Ta Grade 3-4; or multifocal (>2 lesions) Stage Ta any Grade. Must have rec'd at least 2 previous courses of intravesical BCG up to 3 yrs prior to reg. May have rec'd 1 course of chemo. Must not have rec'd gemcitabine prior to reg. Must have had a TURBT or bladder bx documenting above stage & grade at least 6 wks after last BCG and/or immunotherapy or at least 14 days after previous intravesical chemo and w/in 60 days prior to reg. All visible tumor must have been resected at last bx. Must have available representative slides for central path review. Must have had a negative upper tract imaging study w/in 2 yrs of reg w/no evidence of urethral or renal pelvis TCC. Must not have rec'd any prior pelvic RT nor planning to receive any concurrent RT. Must be offered opportunity to consent for specimen submission per Section 15. Must have Zubrod PS 0-2.