 - Adequate renal and hepatic function, defined as: Total serum bilirubin 2 x upper limit of normal ULN for the institution; aspartate aminotransferase AST andor alanine aminotransferase ALT 2.5 x ULN for the institution 5 x if due to hepatic metastases; Serum albumin 2 gdL; Serum creatinine 2 x ULN for the institution 