Table 1.
Adequate organ function laboratory values
| System | Laboratory Value |
|---|---|
| Hematological | |
| 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) |
| Renal | |
| Serum creatinine | ≤1.5 X upper limit of normal (ULN) |
| OR | OR |
|
Measured or calculateda 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 |
| Hepatic | |
| 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 |
| Coagulation | |
| 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 |
aCreatinine clearance should be calculated per institutional standard