Trastuzumab (Herceptin), Paclitaxel, Carboplatin and Gemcitabine in Advanced Urothelial Cancer

Exclusion Criteria

• •All patients must have a blood sample drawn for HER2 serologic testing.
• •If the available tissue is from the primary tumor and is HER2 negative and if the serum is negative, to qualify for the study a biopsy of a metastatic site should be done and the patient will be eligible ONLY if this demonstrates HER2 over-expression.
• •Patients may not have received prior systemic chemotherapy for metastatic disease. Patients may have received adjuvant chemotherapy if completed at least 6 months prior to beginning this protocol treatment.
• •Patients may not have cardiac disease and must have adequate cardiac function (ejection fraction \> 50% or higher than the lower limit of institutional normal) as determined by a MUGA scan or 2-D echocardiogram within 4 weeks from registration, and no evidence of symptomatic coronary artery disease (baseline EKG must show no active ischemia). Patients must not have history of congestive heart failure.
• •If patients have received prior radiation therapy, disease must be present outside of radiated fields and at least 4 weeks must have elapsed since discontinuation of that therapy.
• •Pregnant or lactating women may not participate.
• •HIV - positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.