- Adequate organ system function as defined in Table 9. Absolute neutrophil count (ANC)>/= 1.0 X 109/L; Hemoglobin >/= 9 g/dL; Platelets >/= 75 X 109/L; PT/INR and PTT </= 1.3 X ULN; Total bilirubin </=1.5 mg/dL; AST and ALT </= 2.5 X ULN (can be higher in the presence of liver metastasis.); Creatinine </= ULN OR Calculated creatinine clearance >/= 50 mL/min OR 24-hour urine creatinine clearance >/= 50 mL/min; Ejection fraction >/= LLN by ECHO or MUGA.