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A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer

Primary To determine the acute toxicity (90 days from protocol treatment start) from chemoradiotherapy including paclitaxel ± trastuzumab and irradiation in non-cystectomy patients with or without her2/neu overexpression. Secondary To determine the ability of patients with bladder cancer who are non-cystectomy candidates to complete this treatment program. To evaluate the efficacy of this treatment program in achieving a complete response of the primary tumor. To measure the 5-year disease-free and overall survival of patients with bladder cancer treated with TURB followed by chemoradiotherapy. To estimate the value of tumor and/or serum biomarkers as predictors of initial tumor response and recurrence-free survival.

Primary To determine the acute toxicity (90 days from protocol treatment start) from chemoradiotherapy including paclitaxel ± trastuzumab and irradiation in non-cystectomy patients with or without her2/neu overexpression. Secondary To determine the ability of patients with bladder cancer who are non-cystectomy candidates to complete this treatment program. To evaluate the efficacy of this treatment program in achieving a complete response of the primary tumor. To measure the 5-year disease-free and overall survival of patients with bladder cancer treated with TURB followed by chemoradiotherapy. To estimate the value of tumor and/or serum biomarkers as predictors of initial tumor response and recurrence-free survival.