A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin with Molecular Correlates

Pts must have histologically confirmed muscle invasive (T2-T4a) node negative (N0)urothelial (transititional cell) ca of the bladder. See Section 5.1 re: mixed histologies. Measurable disease is not req'd. Pts must have muscle invasive disease w/no clinical evidence of mets diagnosed by TURBT. Pts must have had an initial TURBT as well as a repeat TURBT to confirm presence of persistent disease. Muscle invasion must be demonstrated from tumor specimen(s) obtained from either initial or repeat TURBT. The repeat TURBT must have been done w/in 16 wks of the first TURBT w/the attempt to remove all tumor present. Reg must occur at least 14 days, but no longer than 56 days after the 2nd TURBT. Pts must have pre-tx fresh or parafin tumor tissue or unstained slides or cell block specimens available from at least one of the prestudy TURBTs and agree to have specimens submitted for analysis. Pts must not have rec'd any prior systemic chemo or RT for this malignancy. Pts must not be planning to recieve any concurrent RT. Prior intravesical chemo/immunotherapy is allowed. Chest PA-Lateral fils and CT or MRI of the abd/pelvis must be obtained w/in 28 days of reg. Pts must have WBC > / = 3500; AGC > / = 1500, PLT > / = ILLN; bili < / = 1.5 mg/dL, SGOT < / = 2 x IULN, creatinine < / = 2.0 mg/dl and/or calculated CrCl > / = 60 ml/minute w/in 28 days prior to reg. Pts must have a Zubrod PS of 0-2.