 7. Adequate liver and renal function obtained 14 days prior to enroll: AST SGOT, ALT SGPT 2.5 × upper limit of normal range ULN, unless liver metastases are clearly present, then 5 × ULN is allowed; Total bilirubin 1.5 ULN; Serum creatinine within normal limits or calculated clearance 60 mLmin1.73 m2 