6. Demonstrate adequate organ function as described, all screening labs should be performed within 10-15 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 erythropoietin (EPO) dependency (within 7 days of assessment); RENAL: Serum creatinine </= 1.5 X upper limit of normal (ULN) or Measured or calculated creatinine clearance (glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl)) >/=60 mL/min for subject with creatinine levels > 1.5 X institutional ULN;