 - The subject has adequate organ function, defined as follows A. Bilirubin 1.5 x the upper limit of normal ULN B. Serum creatinine 1.5 x UNL or calculated creatinine clearance 60 mLmin, and C. For subjects without liver metastases: alanine aminotransferase ALT and aspartate aminotransferase AST 2.5 x ULN D. For subjects with liver metastases: alanine aminotransferase ALT and aspartate aminotransferase 5 x ULN 