5. Inclusion #5 continued: alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) </=2.5 X ULN or </=5 X ULN for subjects with liver metastases *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