- The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to study entry must be met: Total bilirubin must be less than or equal to 1.0 x upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be less than or equal to 2.5 x ULN for the lab or less than or equal to 5 x ULN if liver metastasis; Alkaline phosphatase must be less than or equal to 3 x ULN for the lab or less than or equal to 5 x ULN if liver metastasis