4. Patients must have normal organ and marrow function as defined below: Absolute neutrophil count ≥1,500/μL, Platelets ≥100,000/μL, Hemoglobin > 9g/dL (transfusion allowed), Total bilirubin within normal range, or ≤1.5 X upper limit of normal (ULN) if liver metastases are present; or total bilirubin ≤3 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome. AST(SGOT)/ALT(SGPT) within normal limits (WNL), except for patients with tumor involvement of the liver who must have AST and ALT ≤3 X ULN Serum creatinine ≤1.5 X ULN OR 24-hour creatinine clearance ≥60 mL/min Amylase and lipase levels WNL Fasting plasma glucose ≤120 mg/dL (7.8 mmol/L), INR ≤2.