Bilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1)
Bilirubin =< 1.5 x ULN
Patients must have a total serum bilirubin =< 1.5 x ULN (grade =< 1) and a serum creatinine =< grade 1
Patients with abnormal liver function will be eligible and will be grouped according to the criteria below* Group A (normal hepatic function)** Bilirubin =< upper limit of normal (ULN) and aspartate aminotransferase (AST) =< ULN* Group B (mild hepatic dysfunction)** B1: bilirubin =< ULN and AST > ULN** B2: bilirubin > ULN but =< 1.5 x ULN and any AST* Group C (moderate hepatic dysfunction)** Bilirubin > 1.5 x ULN to =< 3 x ULN and any AST* Group D (severe hepatic dysfunction) ** Bilirubin > 3 x ULN and up to investigators discretion and any AST* Patients with active hemolysis should be excluded; no distinction will be made between liver dysfunction due to metastases and liver dysfunction due to other causes; registration laboratory investigations will be used to assign a patient to a hepatic function group; liver function tests should be repeated within 24 hours prior to starting initial therapy and may result in the patients' group assignment being altered if different to registration test results
Bilirubin =< 1.5 x ULN
Total bilirubin =< 2.0, within 30 days prior to enrollment
Patients with abnormal hepatic function will be eligible and will be grouped according to criteria summarized below:* Group A: Normal hepatic function** Bilirubin =< ULN** Aspartate aminotransferase (AST) =< ULN* Group B: Mild hepatic dysfunction** B1: bilirubin =< ULN and AST > ULN** B2: ULN < bilirubin =< 1.5 x ULN and any AST* Group C: Moderate hepatic dysfunction** 1.5 x ULN < bilirubin =< 3 x ULN and any AST* Group D: Severe hepatic dysfunction** 3 x ULN < bilirubin =< 10 x ULN and any AST; hepatic function tests should be repeated within 24 hours prior to starting initial therapy and may result in patients� group assignment being altered if different to registration test results
Bilirubin =< 1.5 x ULN; for subjects with liver metastases =< 3 x ULN is allowed
Total serum bilirubin =< 1.5 x ULN
Serum total bilirubin =< 1.5 X upper limit of normal (ULN) or direct bilirubin =< ULN for patients with total bilirubin levels > 1.5 ULN
Total bilirubin < 1.5 x ULN
Total bilirubin =< 1.5 x upper limit of normal (ULN) in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); also, if hyperbilirubinemia is clearly attributed to liver metastases total bilirubin =< 3 x ULN is permitted
Re-registration: total bilirubin =< 1.5 x ULN in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); if hyperbilirubinemia is clearly attributed to liver metastases, total bilirubin =< 3 x ULN is permitted
Total bilirubin =< 1.5 x ULN
Total bilirubin =< 1.5 x the institutional ULN
If no known liver metastases: total bilirubin < 1.5 x institutional upper limit of normal (ULN); if known liver metastases, then: total bilirubin < 2.5 x ULN
Total serum bilirubin =< 1.5 x ULN (in patients with known Gilbert syndrome, a total bilirubin =< 3.0 x ULN, with direct bilirubin =< 1.5 x ULN)
Total bilirubin =< 1.5 x ULN (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 x ULN), within 4 weeks of randomization
Serum total bilirubin: =< 1.5 X ULN OR
Direct bilirubin: =< ULN for patients with total bilirubin levels > 1.5 ULN
Total bilirubin =< 1.5 x ULN within 14 days prior to registration.
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Within 14 days prior to registration: Total Bilirubin =< 1.5 x ULN (patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
Total bilirubin:* If no known liver metastases: total bilirubin < 1.5 x institutional upper limit of normal (ULN)* If known liver metastases, then: total bilirubin < 2.5 x ULN
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)