- Chemotherapy: Patients may have received up to 1 prior line of gemcitabine based systemic therapy (single agent or combination therapy) for locally advanced or metastatic disease. Prior therapy with inhibitors of angiogenesis is permitted. All toxicities must be resolved to < Grade 1 (CTCAE v 3.0) and the last dose must have been given at least 4 weeks prior to randomization.