 - Serum transaminases aspartate transaminase AST or alanine transaminase ALT activity less than or equal to 2.5 X ULN with normal alkaline phosphatase patients with liver metastases less than or equal to 5 x ULN OR AST and ALT less than or equal to 1.5 X ULN with an alkaline phosphatase greater than 2.5 X ULN 