1. Prior chemotherapy or target therapy with another systemic anti-cancer agent (e.g., monoclonal antibody, tyrosine kinase inhibitor) for the treatment of the patient's current stage of disease (Stage IIIB not amenable for combined modality treatment, stage IV or recurrent disease). Prior surgery and irradiation is permitted, provided that the criteria outlined in the protocol for both treatments are met. Disease progressed within 6 months after adjuvant therapy must be excluded.