9. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1): a) Absolute neutrophil count (ANC) >/= 1500 cells/µ b) White blood cell (WBC) counts > 2500/µL c) Lymphocyte count >/= 500/µL d) Platelet count >/= 100,000/µL; e) Hemoglobin >/= 9.0 g/dL f) Total bilirubin </= 1.5 x upper limit of normal (ULN) with the following exception: 1) Patients with known Gilbert disease who have serum bilirubin level </= 3 x ULN may be enrolled. g) AST and ALT </= 2.5 x ULN with the following exception: 1) Patients with documented liver metastases: AST and/or ALT </= 5 x ULN h) Alkaline phosphatase </= 2.5 x ULN with the following exception: 1) </= 5 x ULN in patients with documented liver metastases </=7 x ULN in patients with documented bone metastases