7. Inclusion #6 continued--HEPATIC: Serum total bilirubin </= 1.5 X ULN or Direct bilirubin </= ULN for subjects with total bilirubin levels > 1.5 ULN; 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