8. Demonstrate adequate organ function as defined below, all screening labs should be performed within 28 days prior to study registration: *Hematological: Absolute neutrophil count (ANC) >/=1,000 /mcL; Platelets >/=50,000 / mcL; Hemoglobin >/=9 g/dL or >/=5.6 mmol/L; *Renal: Serum creatinine </=1.5 X upper limit of normal (ULN) or measured or calculated creatinine clearance (CrCl) (Glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl) >/=40 mL/min creatinine clearance (CrCl) using the Cockcroft-Gault Formula. *Hepatic: Serum total bilirubin </=1.5 X ULN (except for subjects with Gilbert Syndrome, who may have total bilirubin <3.0 mg/dl) or Direct bilirubin </= ULN for subjects with total bilirubin levels > 1.5 X ULN; aspartate aminotransferase (AST SGOT) and alanine aminotransferase (ALT SGPT) </= 3 X ULN or </= 5 X ULN for subjects with liver metastases