4. Demonstrate adequate organ function as defined here, all screening labs should be performed within 10 days of treatment initiation: Adequate Organ Function Laboratory Values- * Hematological; Absolute neutrophil count (ANC) >/=1,500 /mcL, Platelets >/=100,000 / mcL, Hemoglobin >/=9 g/dL or >/=5.6 mmol/L * Renal; Serum creatinine or Measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) </=1.5 X upper limit of normal (ULN) or >/=60 mL/min for subject with creatinine levels >1.5 X institutional ULN [Creatinine clearance should be calculated per institutional standard] *Hepatic; Serum total bilirubin </=1.5 X ULN or Direct bilirubin </=ULN for subjects with total bilirubin levels >1.5 ULN, aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and