Table 1 Adequate organ function laboratory values
System | Laboratory value |
|---|---|
Hematological | |
 Absolute neutrophil count | ≥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) |
Renal | |
 Serum creatinine OR Measured or calculateda creatinine clearance | ≤1.5 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 | ≥25 g/L |
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 |