- Subjects must have adequate hematological, hepatic, and renal function as defined: Hematologic: absolute neutrophil count (ANC) ≥1.5 X 10^9/L, hemoglobin ≥10 g/dL, platelets ≥100 X 10^9/L; Hepatic: serum bilirubin≤ upper limit of normal (ULN), AST and ALT ≤ 5 x ULN if documented liver metastases, AST and ALT ≤ 3 X ULN without liver metastases; Renal: calculated creatinine clearance ≥50 mL/min.