Inclusion Criteria:

- Biopsy-proven metastatic bladder cancer

- No prior chemotherapy for metastatic disease except before or after surgery, which
was completed 6 months before enrollment

- Prior radiation allowed, if it is not the only site of measurable disease and if
completed 3 weeks before enrollment

- 18 years of age and older

Exclusion Criteria:

- Pure adeno- or squamous urothelial cancer

- Brain metastases that causes symptoms

- Have not received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication

- Inability to take dexamethasone, folic acid or vitamin B12, according to the protocol

- Clinically relevant fluid collection in the lungs or abdomen that cannot be
controlled