Table 1 Adequate organ function laboratory values

 Absolute leukocyte count

≥2500 /mcL

 Absolute lymphocyte count (ALC)

≥500 /mcL

 Absolute neutrophil count (ANC)

≥1500 /mcL

 Platelets

≥100,000 / mcL

 Hemoglobin

≥9 g/dL or ≥ 5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)

 Serum creatinine

≤1.5 X upper limit of normal (ULN)

 OR

OR

 Measured or calculated^a creatinine clearance

(GFR can also be used in place of creatinine or CrCl)

≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN

 Serum total bilirubin

≤ 1.5 X ULN

 OR

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

> 2.5 mg/dL

 International Normalized Ratio (INR) or Prothrombin Time (PT)

≤1.5 X ULN unless subject is receiving anticoagulant therapyas long as PT or PTT is within therapeutic range of intended use of anticoagulants

 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