9. Inclusion #8 cont'd: aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (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 therapy as 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