8. Demonstrate adequate organ function as defined below, all screening labs should be performed within 10 days of treatment initiation. *HEMATOLOGICAL: Absolute neutrophil count (ANC) = >/=1,500 /mcL; Platelets = >/=100,000 / mcL; Hemoglobin = >/=9 g/dL or >/=5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) *RENAL: Serum creatinine OR Measured or calculated creatinine clearance (creatinine clearance should be calculated per institutional standard) (GFR can also be used in place of creatinine or CrCl) = </=1.5 X upper limit of normal (ULN) OR >/=60 mL/min for subject with creatinine levels > 1.5 X institutional ULN *HEPATIC: Serum total bilirubin = </= 1.5 X ULN OR Direct bilirubin </= ULN for subjects with total bilirubin levels > 1.5 ULN;