Total bilirubin =< 2.0 mg/dl Total bilirubin ? 2 mg/dL Total bilirubin =< 1.5 mg/dL Total serum bilirubin =< 2.0 mg/dL Total bilirubin =< 1.5 mg/dL or < 2 mg/dL if attributable to hepatic infiltration by neoplastic disease Total bilirubin =< 1.5 mg/dL (25.65 umol/L) Total serum bilirubin > 2 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin ? 2.0 mg/dl Total bilirubin =< 1.5 mg/dL Total bilirubin =< 3 mg/dL Total bilirubin =< 1.5 mg/dL ARM 2 - A: Total bilirubin =< 2.0 mg/dL Total bilirubin ? 1.5mg/dl, Total bilirubin of ? 1.5 mg/dL or ? 2.0 mg/dL for subjects with liver metastasis. Total bilirubin < 1.5 mg/dL PART I: Total bilirubin =< 1.5 mg/dl Total bilirubin =< 2.0 mg/dL Total bilirubin =< 2.0 mg/ml ARM I&II: Total bilirubin =< 1.5 mg/dl Total bilirubin =< 1.5 mg/dL Total bilirubin =< 3.0 mg/dL Total bilirubin ? 3.0 mg/dL Within 14 days of the first dose of the study drugs: Total bilirubin =< 1.5 mg/dl. Total bilirubin > 3 mg/dl Within 14 days of the first dose of study drug: Total bilirubin =< 1.5 mg/dl Total bilirubin =< 1.5 mg/dL within 30 days of registration Total serum bilirubin =< 1.5 mg/dl Total bilirubin =< 2.0 mg/dl Total bilirubin =< 1.5 mg/dl (For both cohorts A and B): Total serum bilirubin =< 2.0 mg/dL Total bilirubin < 2 mg/dl Total bilirubin =< 2 mg/dL Total bilirubin less than or equal to 2.0 mg/dl Total bilirubin =< 2.5 mg/dl within 30 days of enrollment to study Total bilirubin ? 1.5 mg/dl Total bilirubin =< 2.0 mg/dL\r\n* If Gilbert's disease is suspected and total bilirubin > 2.0 mg/dL, direct bilirubin must be =< 2.0 mg/dL Total bilirubin =< 1.5 mg/dl within 14 days prior to study entry Total bilirubin =< 1.5 mg/dl Subjects with total bilirubin > 2.0 mg/dL at day 1 are not eligible for enrollment Total bilirubin =< 1.5 mg/dL Total bilirubin =< 1.5 mg/dL PHASE II: Total bilirubin =< 1.5 mg/dL Total bilirubin < 2 mg/dl Total bilirubin =< 2mg/dL, obtained within 14 days of first dose of drug Total bilirubin =< 1.5 mg/dL (25.65 umol/L) Total bilirubin =< 1.5 mg/dL Total bilirubin =< 1.5 mg/dl Total bilirubin =< 2 mg/dL (unless directly attributable to lymphoma) Total bilirubin less than or equal to 2.0 mg/dl Serum total bilirubin =< 1.5 mg/dL Total or direct bilirubin =< 1.5 mg/dL Total bilirubin < 1.5 mg/dL. Total bilirubin =< 1.6 mg/dL Total bilirubin < 3 mg/dL Total bilirubin =< 2.0 mg/dL Total bilirubin =< 3.0 mg/dl Total bilirubin =< 2.0 mg/dL Total serum bilirubin =< 2.0 mg/dL Total bilirubin =< 2.5 mg/dL Total bilirubin > 3 mg/dL Total bilirubin < 2.0 mg/dL Total bilirubin =< 5.0 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin < 1.5 mg/dl Total bilirubin =< 1.6 mg/dL prior to biopsy Total bilirubin =< 3 mg/dL Total bilirubin less or equal to 2 mg/dl Total bilirubin =< 1.5 mg/dl within 14 days of the first dose of study drug Total bilirubin =< 2.0 mg/dl Total bilirubin >= 1.5 mg/dL and not related to hemolysis or Gilbert's disease; patients with total bilirubin >= 1.5 mg/dL to 3 mg/dL are eligible if at least 75% of the bilirubin is indirect Total bilirubin =< 2 mg/dL Within 30 days of first vaccination: Total bilirubin =< 1.5 mg/dl Total bilirubin =< 2.0 mg/dL Total bilirubin =< 2.5 mg/dL Total bilirubin ? 3.0 mg/dL Total serum bilirubin > 1.5 mg/dl Total bilirubin =< 2 mg/dL Total serum bilirubin =< 2.0 mg/dL Total bilirubin < 2 mg/dL Total bilirubin =< 2.0 mg/dL Total serum bilirubin > 1.5 mg/dl Total bilirubin < 2 mg/dL Total bilirubin =< 2 mg/dl Total bilirubin =< 2 mg/dl Total bilirubin =< 2 mg/dL Total serum bilirubin > 2 mg/dL Total bilirubin =< 2.0 mg/dl Total bilirubin =< 1.5 mg/dL Total bilirubin =< 2 mg/dL Total bilirubin > 2.0 mg/dl Total serum bilirubin > 1.5 mg/dl Total bilirubin < 3 mg/dl Serum total bilirubin < 2.5 mg/dl Total serum bilirubin > 1.5 mg/dl The total serum bilirubin =< 2.5 mg/dL Total bilirubin =< 2.0 mg/dl Total bilirubin =< 2.0 mg/dl Total bilirubin >1.5 mg/dL Total bilirubin ?1.5 mg/dL. Total bilirubin ?2mg/dl Total bilirubin =< 2.2 mg/dL Serum total bilirubin < 1.5 mg/dL Bilirubin (total) =< 1.7 mg/dL Total bilirubin =< 2.0 mg/dL Total bilirubin ?1.5 × ULN or total bilirubin of ?2 mg/dL, whichever is higher. Total bilirubin < 2.0 mg/dl Total bilirubin =< 2 mg/dl (biliary stent is allowed) Total bilirubin =< 1.5 mg/dL Total bilirubin =< 2.0 mg/dL Within 14 days of registration: Total bilirubin =< 2.0 mg/dL Total bilirubin =< 2mg/dL. Total bilirubin < 2.0 mg/dl Total bilirubin =< 2 mg/dl unless high indirect bilirubin is due to a congenital disorder Total bilirubin: =< 2.0 mg/dL Total bilirubin =< 2.0 mg/dl Total bilirubin < 2.0 mg/dL Total bilirubin =< 4.0 mg/dl Total bilirubin =< 1.5 mg/dL Total bilirubin < 1.5 mg/dL Total bilirubin =< 2.0 mg/dl Total bilirubin =< 1.5 mg/dL No history of severe prior or ongoing chronic liver disease; total bilirubin =< 2.0 mg/dl Total bilirubin =< 2.2 mg/dL Total bilirubin >= 1.5 mg/ml Total bilirubin =< 5 mg/dL Total bilirubin =< 2.0 mg/dL Total bilirubin =< 2.0mg/dL Total bilirubin less than or equal to 2 mg/dL Total bilirubin =< 1.5 mg/dl Within 56 days prior to randomization: Serum total bilirubin < 3.0 mg/dL Total bilirubin =< 2 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin =< 3.0 mg/dl Total bilirubin =< 2.0 mg/dL Total bilirubin =< 1.5 mg/dl Total bilirubin ?1.5 mg/dL Total bilirubin < 2.0 mg/dL Serum total bilirubin =< 2.0 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin =< 2 mg/dL Total bilirubin < 2.0 mg/ dl Total serum bilirubin =< 2.0 mg/dL Total bilirubin =< 1.5 mg/dl Total bilirubin =< 1.5 mg/dl Total bilirubin =< 2 mg/dl unless high indirect bilirubin is due to a congenital disorder Total bilirubin =< 1.5 mg/dL or < 2 mg/dL if attributable to hepatic infiltration by neoplastic disease Total bilirubin =< 2.0 mg/dL Total serum bilirubin =< 2 mg/dL Total bilirubin =< 1.5 mg/dl Total bilirubin within normal limits, 0–1 mg/dL Total bilirubin < 2.0 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin =< 5.0 mg/dL Serum total bilirubin > 2.0 mg/dL Total bilirubin < 1.5 mg/dl Total bilirubin =< 1.5 mg/dL Total bilirubin =< 3.0 mg/dL Total bilirubin =< 1.5 mg/dl Total bilirubin =< 2.5 mg/dl Total bilirubin =< 1.5 mg/dl Total bilirubin =< 3.0 mg/dL Total bilirubin =< 3.0 mg/dL and no evidence of bile obstruction Total bilirubin =< 3 mg/dL Total or direct bilirubin =< 1.5 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin =< 1.5 mg/dl Total bilirubin =< 2.0 mg/dl Total bilirubin =< 1.5 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin < 2.0 mg/dl Total bilirubin =< 1.5 mg/dL Total bilirubin =< 2.0 mg/dL Total bilirubin =< 2.0 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin =< 1.5 mg/dL Total serum bilirubin < 1.5 mg/dL Total bilirubin > 3 mg/dL Total serum bilirubin =< 1.5 mg/dL Total bilirubin =< 3 mg/dL Total bilirubin < 1.5 mg/dL Total bilirubin <1.6 mg/ml Total bilirubin >= 1.5 mg/dL and not related to hemolysis or Gilbert's disease; patients with total bilirubin >= 1.5 mg/dL to 3 mg/dL are eligible if at least 75% of the bilirubin is indirect Total bilirubin =< 2 mg/dl (biliary stent is allowed) Total bilirubin =< 1.5 mg/dl, within 14 days of registration Total bilirubin =< 2.0 mg/dl Total bilirubin =< 3 mg/dL Total bilirubin less than or equal to 2.0 mg per dL Total bilirubin < 1.5 mg/dl Total bilirubin of =< 1.5 mg/dl Total bilirubin < 2 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin =< 1.5 mg/dL =< 10 days prior to enrollment/randomization: Total bilirubin =< 1.5 mg/dl Total bilirubin =< 3.0 mg/dL Patient has total bilirubin > 2.5 mg/dL. Total bilirubin =< 1.5 mg/dl Serum total bilirubin of at least 3 mg/dL Total bilirubin =< 2 mg/dL Total bilirubin < 2.5 mg/dl Total serum bilirubin > 2.0 mg/dl Total bilirubin ?1.5 mg/dL Total bilirubin < 2.0 mg/dL Total bilirubin =< 2.0 mg/dL Total bilirubin =< 2.5 mg/dL Total bilirubin =< 2.0 mg/dl Total bilirubin =< 1.5 mg/dl Serum total bilirubin =< 2.0 mg/dL Total bilirubin =< 3 mg/dl Total bilirubin =< 2 mg/dL Total bilirubin >2.5 mg/dL Total bilirubin ?2 mg/dL Total bilirubin ?3.0 mg/dL Total bilirubin =< 2.5 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin =< 2.5 mg/dl Total bilirubin of ? 1.5 mg/dL or ? 2.0 mg/dL for subjects with liver metastasis Total bilirubin < 1.5 mg/dl Total bilirubin =< 2.0 mg/dL Total bilirubin < 4.0 mg/dl Total bilirubin =< 2.5 mg/dL Total bilirubin ?3.0 mg/dL Must have total serum bilirubin ? 3 mg/dl Total bilirubin < 1.5 mg/dl Total bilirubin =< 1.5 mg/dl Conjugated bilirubin 2.0 mg/dL Total bilirubin =< 3 mg/dl Total bilirubin =< 2.0 mg/dl Total bilirubin < 2.0 mg/dL or < 1.50 x ULN for the institution whichever is higher Total bilirubin < 1.5 X ULN mg/dl Total bilirubin =< 1.5 mg/dl Total Bilirubin > 2 mg/dL Total serum bilirubin ? 2.0 mg/dL Total bilirubin < 2 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin =< 2.5 mg/dl Total serum bilirubin > 2 mg/dL Total bilirubin =< 1.5 mg/dL Total serum bilirubin =< 1.5 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin =< 1.5 mg/dL Total bilirubin equal to or less than 2 mg/dl Total bilirubin =< 3.0 mg/dL (bilirubin =< 1.5 x ULN) Total bilirubin =< 3.0 mg/dL Total bilirubin < 2.0 mg/dl Total bilirubin =< 1.5 mg/dl within 90 days of enrollment Total bilirubin =< 2.0 mg/dl Total bilirubin ?1.5 mg/dL Total serum bilirubin =< 2.0 mg/dL Total bilirubin < 1.5 mg/dl Total bilirubin > 2.0 mg/dL Total bilirubin =< 2.0 mg/dl Total bilirubin ? 1.5 mg/dL Total bilirubin =< 2.0 mg/dL Total serum bilirubin < 2.0 mg/dL, within 2 weeks prior to study start Total bilirubin =< 2 mg/dL Total bilirubin < 1.5 mg/dL Total Bilirubin <4.0 mg/dl Total bilirubin =< 1.5 x ULN mg/dL