Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

Study start date: February 1, 2008

Inclusion Criteria: * Histologically or cytologically confirmed transitional cell carcinoma of the urinary bladder. * Metastatic or locally advanced disease. * No prior chemotherapy. * Performance status (World Health Organization) 0-2. * Measurable or evaluable disease. * Measurable disease is defined as at least 1 unidimensional measurable lesion ≥20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease. * Adequate liver (bilirubin ≤ 1.5 Upper Normal Limit, serum glutamate-pyruvate aminotransferase/serum glutamic pyruvic transaminase ≤ 2 Upper Normal Limit, ALP ≤ 2.5 Upper Normal Limit), renal (creatinine ≤ 1.5 Upper Normal Limit) and bone marrow (absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3) function. * Life expectancy \> 3 months. * Patients must be able to understand the nature of this study and give written informed consent. Exclusion Criteria: * History of serious cardiac disease (unstable angina, severe congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias). * Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer. * Active infection. * Uncontrolled inflammation. * Pregnant or lactating women. * Psychiatric illness or social situation that would preclude study compliance.