8. Adequate Organ Function Laboratory Values: HEMATOLOGICAL=Absolute neutrophil count (ANC) >/=1,000 /mcL; Platelets >/= 100,000 /mcL; Hemoglobin >/= 9 g/dL or >/= 5.6 mmol/L. RENAL=Serum creatinine or Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) </=1.5 X upper limit of normal (ULN) or >/= 40 mL/min 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 the liver metastases