Demonstrate ad equate organ function as defined in 6. Table 1, all screening labs should be performed within 30 days of treatment initiation. Table 1 Adequate Organ Function Laboratory Values System Laboratory Value Hematolo gical Absolute neutrophil count (ANC) ≥1,000 /mcL Platelets ≥75,000 / mcL Hemoglobin ≥8 g/dL Renal Serum creatinine OR Measured or calculateda CrCl (GFR can also be used in place of creatinine or CrCl) ≤2.0 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 AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases Albumin >3.0 mg/dL Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants aCreatinine clearance (CrCl) should be calculated per institutional standard. 7.