--- a +++ b/clusters/9knumclustersv2/clust_1216.txt @@ -0,0 +1,26 @@ +INCLUSION CRITERIA FOR SECOND-LINE THERAPY: For patients with known hepatic metastases, AST and ALT =< X the upper normal limit of institution's normal range +INCLUSION CRITERIA FOR THIRD-LINE THERAPY: AST and ALT =< X the upper normal limit of institution's normal range +INCLUSION CRITERIA FOR THIRD-LINE THERAPY: For patients with known hepatic metastases, AST and ALT =< X the upper normal limit of institution's normal range +Patients with -hydroxyindoleacetic acid (HIAA) levels above or below the upper limit of normal range (normal: to mg/ hours) and those with unknown values at baseline are allowed to participate +AST and ALT ? . X the upper normal limit of institution's normal range +Total bilirubin ? . X the upper normal limit of institution's normal range +PT and PTT must be ? . X upper normal limit of institution's normal range +Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< . x the upper normal limit of institution's normal range, at the time of enrollment; for subjects with liver metastases, AST and ALT =< x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia +Total bilirubin =< . x the upper normal limit of institution's normal range, at the time of enrollment; for subjects with liver metastases, total bilirubin > . - . x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia +Must have had an elevated serum CA level twice the upper limit of normal (per reference lab normal range) measured within weeks of enrollment. +Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< . x the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia +Total bilirubin =< . x the upper normal limit of institution's normal range; for subjects with liver metastases, total bilirubin > . - . x the upper normal limit of institution's normal range are acceptable as long as there is no persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia +Bilirubin =< . X the upper normal limit of institution's normal range +Partial thromboplastin time (PTT) must be =< X upper normal limit of institution's normal range; subjects on anticoagulant (such as coumadin) must have a PTT =< X upper normal limit of institution's normal range +Non-fasting bilirubin =< . X the upper normal limit of institution's normal range +Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< . the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < the upper normal limit of institution's normal range AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia +Non-fasting direct bilirubin =< . the upper normal limit of institution's normal range +Partial thromboplastin time (PTT) must be =< . upper normal limit of institution's normal range +Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< . the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < the upper normal limit of institution's normal range are acceptable AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia; the combination of -FU and oxaliplatin is known to be safe to be administered in patients with such abnormal liver function tests +Non-fasting direct bilirubin =< . the upper normal limit of institution's normal range; for subjects with liver metastases, non-fasting direct bilirubin > .-. x the upper normal limit of institution's normal range are acceptable AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia; the combination of -FU and oxaliplatin is known to be safe to be administered in patients with such abnormal liver function tests +Partial thromboplastin time (PTT) must be =< . upper normal limit of institution's normal range +Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< . X the upper normal limit of institution's normal range; for subjects with liver metastases, AST and ALT < X the upper normal limit of institution's normal range AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia +Non-fasting bilirubin =< . X the upper normal limit of institution's normal range; non-fasting bilirubin . - . X the upper normal limit of institution's normal range are acceptable AS LONG AS THERE IS NO persistent nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, or eosinophilia +Hepatic function: AST and ALT ? . the upper normal limit of institution's normal range. For subjects with liver metastases, AST and ALT ? the upper normal limit of institution's normal range; +Bilirubin: ? . the upper normal limit of institution's normal range. +Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone marrow: Absolute neutrophil count (ANC) >/= ,/mm Platelets >/= ,/mm; Hemoglobin >/= . g/dL Renal function: Serum creatinine </= . times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) </= . times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of </= . x the upper limit of normal.