Within 28 days prior to registration: Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for documented/suspected Gilbert’s disease, total bilirubin =< 3.0 x IULN
Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to sub-study registration; for patients with liver metastases, bilirubin must be =< 5 x IULN
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x upper limit of normal [ULN] with Gilbert’s syndrome)
Total bilirubin =< 2.5 x institutional upper limit of normal (IULN) (except patients with Gilbert’s syndrome) within 28 days prior to registration
Patients must have AST and ALT =< 2.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s syndrome, who must have a total bilirubin < 3.0 mg/dL), obtained within 28 days prior to step 2 registration
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (=< 5 x IULN if secondary to lymphoma, Gilbert’s syndrome, or medication related [e.g., indinavir, tenofovir, atazanavir]) within 28 days prior to registration
Obtained within 28 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 3.0 x IULN with Gilbert's syndrome)
AST and ALT =< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration
Registration Step 3 – Maintenance: Patients must have total bilirubin < 2.0 x institutional upper limit of normal (IULN) within 14 days prior to registration
Within 10 days of treatment initiation: Institutional normalized ratio (INR) =< 1.5 X institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< institutional upper limit of normal (IULN) or total bilirubin =< 3.0 x IULN with direct bilirubin within normal range in patients with documented Gilbert’s syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); no prior history of Gilbert’s syndrome
Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
Total bilirubin ? 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 2 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s syndrome, who must have a total bilirubin < 3.0 mg/dL)
Total bilirubin ? institutional upper limit of normal (IULN); patients with Gilbert’s syndrome may enroll if direct bilirubin ? 1.5 x IULN
Total bilirubin =< 2 X institutional upper limit of normal (IULN)
Total bilirubin ? 1.5 x institutional upper limit of normal (IULN) (unless due to diagnosis of Gilbert’s syndrome)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< institutional upper limit of normal (IULN)
Total bilirubin =< institutional upper limit of normal (IULN)
Bilirubin levels > 1.5 institutional upper limit of normal (IULN)
Serum bilirubin < 1.5 x institutional upper limit of normal (IULN) (except for patients with known Gilbert’s disease)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin < 1.5 x institutional upper limit of normal (IULN)
Total bilirubin less than 1.5 X institutional upper limit of normal (IULN) except in patients with Gilbert’s syndrome who must have a total bilirubin less than 2.5 X IULN
Total bilirubin =< international upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
ARM B COHORT 2: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum creatinine =< 1.5 x institutional upper limit of normal (IULN)
Patient must have adequate hepatic function as defined by total bilirubin < 2.5 x IULN (institutional upper limit of normal)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =<1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except participants with Gilbert’s Syndrome who must have normal direct bilirubin)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum bilirubin =< institutional upper limit of normal (IULN); for patients with liver metastases, bilirubin must be =< 5 x IULN obtained within 28 days prior to Step 2 re-registration
Serum bilirubin =< institutional upper limit of normal (IULN); for patients with liver metastases, bilirubin must be =< 5 x IULN within 28 days prior to Step 2 re-registration
Serum bilirubin =< institutional upper limit of normal (IULN); for patients with liver metastases, bilirubin must be =< 5 x IULN within 28 days prior to step 2 re-registration
Within 14 days of subject registration: Total bilirubin within normal range or =< 1.5 X institutional upper limit of normal (IULN) if liver metastases are present or total bilirubin =< 3.0 X IULN with direct bilirubin within normal range in subjects with well-documented Gilbert’s syndrome, which is defined as presence of unconjugated hyperbilirubinemia with normal results from complete blood count (CBC) (including normal reticulocyte count and blood smear), normal liver function test results and absence of other contributing disease processes at the time of diagnosis
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Obtained within 28 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Creatinine < 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 2 x institutional upper limit of normal (IULN) (unless due to Gilbert syndrome) within 42 days prior to registration
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert’s syndrome, who must have a total bilirubin < 3.0 mg/dL) be obtained within 42 days prior to registration
CLINICAL/LABORATORY CRITERIA: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN); these results must be obtained within 28 days prior to registration
Performed within 14 days of patient registration: Total bilirubin within normal range or =< 1.5 x institutional upper limit of normal (IULN) if liver metastases are present or total bilirubin =< 3.0 x IULN with direct bilirubin within normal range in patients with well documented Gilbert’s syndrome, which is defined as presence of several episodes of unconjugated hyperbilirubinemia with normal results from complete blood count (CBC) (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) except in the case of patients with Gilbert’s disease
Total bilirubin within institutional upper limit of normal (IULN)
Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to RE-TREATMENT registration; for patients with liver metastases, bilirubin must be =< 5 x IULN
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Within 14 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< institutional upper limit of normal (IULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (IULN) OR serum bilirubin =< 3.0 x IULN for patients with Gilbert’s disease or documented hepatic involvement with non-Hodgkin lymphoma (NHL)
Within 14 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Direct bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum bilirubin =< institutional upper limit of normal (IULN)
Total serum bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 × the institutional upper limit of the normal range (IULN)
Total bilirubin up to 1.5 X institutional upper limits of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x ULN for patients with Gilbert’s syndrome)
Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Serum bilirubin =< 2 X institutional upper limit of normal (IULN)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Serum bilirubin < 3.0 x institutional upper limit of normal (IULN)
Direct bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) except patients with documented Gilbert’s syndrome within 28 days prior to registration
Total bilirubin =< 2.0 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Transaminases =< 2.5 x institutional upper limit of normal (IULN)
Transaminases =< 2.5 x institutional upper limit of normal (IULN)
Total bilirubin =< 1.5 x the institutional upper limit of normal (IULN) for age
Serum creatinine =< institutional upper limit of normal (IULN)