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.