5. Baseline hematologic studies and chemistry profiles must meet the following criteria: hemoglobin (Hgb) > 9.9 g/dL, absolute neutrophil count (ANC) > 1000/mm3, platelet count > 100,000/mm3, blood urea nitrogen (BUN) < 30 mg/dL, creatinine < 1.4 mg/dL, alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 4x upper limit of normal (ULN), prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6 x control unless therapeutically warranted