NO hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of study treatment start
Hemoglobin >/= 9 g/dL Hepatic Function
Hepatic function as follows:
Adequate hepatic function as evidenced by:
The following criteria for evidence of adequate hepatic function performed within 2 weeks prior to study entry must be met:
Adequate hepatic function
Adequate hepatic function
Subjects with documented hepatic metastases involving >50% of the hepatic parenchyma.
Adequate hepatic function:
Patients must have adequate hepatic function as evidenced by:
The following criteria for evidence of adequate hepatic function performed within 28 days prior to randomization must be met:
Adequate hepatic function
Adequate hepatic function.
Adequate hepatic function, as follows:
Adequate hepatic function
Adequate hepatic profile.
Adequate hepatic profile:
Poorly controlled or refractory (grade 3-4) hepatic encephalopathy
Adequate hepatic function
Hepatic function, as follows:
Adequate hepatic function as defined as follows:
Adequate hepatic function defined as:
The patient has adequate hepatic function per protocol
Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests defined aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline (Alk) phosphatase (Phos), and or total bilirubin greater than 2.5 times the upper limit of normal; patients who have a history of hepatic dysfunction or hepatic disease and normal liver function tests will be eligible to participate
Hepatic function:
Hepatic Function:
Have adequate hepatic function as defined by the following criteria:
Hepatic
Adequate hepatic function:
Has adequate hepatic function, defined as:
The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to study entry must be met:
Patient must not have a diagnosis of hepatic encephalopathy
History of hepatic disease or significant hepatic dysfunction
Adequate hepatic function performed within 4 weeks prior to study entry must be met:
Hepatic metastases
Adequate hepatic function within 48 hours prior to induction chemotherapy
Adequate hepatic function
Have adequate hepatic function
Patients with abnormal hepatic function will be eligible and will be grouped according to criteria; patients with active hemolysis should be excluded; no distinction should be made between liver dysfunction due to metastases and liver dysfunction due to other causes; this data will be captured in the case report form (CRF); registration laboratory investigations will be used to assign a patient to a hepatic function group; 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
Hepatic encephalopathy refractory to medical therapy
Hepatic Function:
Has had clinically diagnosed hepatic encephalopathy in the last 6 months.
Have adequate hepatic function.
Adequate hepatic function
History of hepatic encephalopathy
Any history of hepatic encephalopathy
Ongoing or recent hepatic encephalopathy
Any history of hepatic encephalopathy
Hepatic function:
The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met:
Hepatic function:
Adequate hepatic function
Presence of hepatic encephalopathy within 4 weeks of 1st dose
Patient has adequate hepatic function defined as:
Patients must have adequate hepatic function, defined as
Hepatic
Hepatic encephalopathy
Subjects must have adequate hepatic function as evidenced by:
Adequate hepatic function is defined by the following:
History of hepatic encephalopathy
Hepatic encephalopathy
Subjects must have adequate hepatic function as evidenced by:
Adequate hepatic function as evidenced by serum bilirubin values < 2.0 mg/dL; ALT and/or AST < 3xULN.
Patients with more than 30% replacement of hepatic parenchyma by tumor or any history of drug related hepatic encephalopathy
Adequate hepatic function
Hepatic
Adequate hepatic function with bilirubin < 1.5 mg/dl
Adequate hepatic function.
Must have adequate hepatic function
Adequate hepatic function
Adequate hepatic function
Has adequate hepatic function as evidenced by:
Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests; patients who have a history of hepatic dysfunction or hepatic disease and normal liver function tests will be eligible to participate
Known active hepatic disease
Participants with abnormal hepatic function
Patients must have adequate hepatic function, defined as:
Hepatic:
Hepatic function, as follows:
Hepatic function, as follows:
Recipient must have adequate hepatic function as defined by a total bilirubin <3x upper limit of normal or absence of hepatic fibrosis/cirrhosis.
Adequate hepatic function:
Hepatic encephalopathy, per the investigator's evaluation.
Adequate hepatic function per institutional standards
Alcoholism or hepatic disease.
Adequate hepatic function.
Adequate hepatic function.
Basic metabolic and hepatic function panels
Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests (previously documented alanine aminotransferase greater than 40 IU/dL and/or plasma aspartate aminotransferase greater than 45 IU/d); patients who have a history of hepatic dysfunction or hepatic disease but whose most recent liver function tests have been documented as normal will be eligible to participate
Chronic hepatic disease
Patients with history of hepatic dysfunction or hepatic disease and abnormal liver function tests; patients who have a history of hepatic dysfunction or hepatic disease and normal liver function tests will be eligible to participate
Adequate hepatic function defined as:
No parenchymal hepatic metastases
Clinically detectable hepatic encephalopathy or hepatic encephalopathy requiring medication
Adequate hepatic function within 28 days prior to C1D1
Patients with history of hepatic dysfunction or hepatic disease
Episodes of hepatic encephalopathy within the last 4 weeks. Patients with prior episodes of hepatic encephalopathy who are clinically stable on lactulose, neomycin, and/or xifaxan therapy are allowed.