 - has any of the following hepatic function values: bilirubin greater than 1.5 times the upper limit of normal ULN, alanine aminotransferase ALT or aspartate aminotransferase AST greater than 2.0 times the ULN in the absence of known hepatic metastases, or ALT or AST greater than 3.0 times the ULN in the presence of known hepatic metastases. 