- Hepatic: bilirubin ≤ 3 times the upper limit of normal (× ULN) for patients without tumor involvement of the liver and ≤ 5 X ULN for patients with tumor involvement of the liver; aspartate transaminase (AST) ≤ 2.5 × ULN for patients without tumor involvement of the liver and ≤ 5 X ULN for patients with tumor involvement of the liver