Inclusion Criteria:

- Histologically or cytologically proven urothelial carcinoma of the urinary bladder in
stage T2b-T3, N0/Nx, M0.

- Patients must have measurable disease. Response assessment will be evaluated
according to RECIST criteria. Measurable lesions with clearly defined margins will be
evaluated by X-Ray, Transvesical Ultrasound, CT-Scan or MRI, cystoscopy.

- Lesions serving as measurable disease must have the longest diameter of greater than
or equal to 20 mm as measured with conventional techniques or greater than or equal
10 mm with spiral CT scan. Lesions measured by physical examination must have a
longest diameter of greater than or equal 20 mm.

Exclusion Criteria:

- Patients with prior or concomitant malignant diseases (other than appropriately
treated basal cell carcinoma of the skin or carcinoma of the cervix)

- PSA greater than 5.0 ng/mL

- Concurrent administration of any other tumor therapy, including radiotherapy,
cytotoxic chemotherapy, immunotherapy, molecular target therapy.