Adenocarcinoma of colon | Adenocarcinoma of rectum | Neoplasm Metastasis
Item
histologically confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
C0027627 (UMLS CUI [3])
Prior Chemotherapy Neoplasm Metastasis | fluoropyrimidine | oxaliplatin | Chemotherapy, Adjuvant
Item
one and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and an oxaliplatin-based chemotherapy. prior adjuvant chemotherapy used prior to the onset of metastatic disease is permitted
boolean
C1514457 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0596581 (UMLS CUI [2])
C0069717 (UMLS CUI [3])
C0085533 (UMLS CUI [4])
Measurable lesion Linear Quantity | Disease Site Evaluation
Item
at least one uni dimensionally measurable lesion per modified recist criteria. all sites of disease must be evaluated <= 28 days before randomization
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
Disease Progression Radiography | Prior Chemotherapy Neoplasm Metastasis
Item
radiographically documented disease progression per modified recist criteria either while receiving or <= 6 months after the last dose of prior chemotherapy regimen for metastatic disease
boolean
C0242656 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age
Item
man or woman >= 18 years of age
boolean
C0001779 (UMLS CUI [1])
End Organ Assessment Hematology | End Organ Assessment Chemistry
Item
adequate end organ assessments by laboratory studies (hematological and chemistries)
boolean
C0444930 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0200627 (UMLS CUI [1,4])
C0444930 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0201682 (UMLS CUI [2,4])
Life Expectancy
Item
life expectancy >= 3 months
boolean
C0023671 (UMLS CUI [1])
Malignant Neoplasms | Exception
Item
exclude subjects with a history of prior malignancy, except:
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2])
Curative treatment Malignant Neoplasms | Disease Free of | Disease recurrence Low Risk
Item
malignancy treated with curative intent and with no known active disease present for >= 3 years before enrollment and felt to be at low risk for recurrence by treating physician
boolean
C1273390 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0679254 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
Skin carcinoma Treated | Lentigo maligna Without Evidence of Disease
Item
adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
boolean
C0699893 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0149722 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0332120 (UMLS CUI [2,3])
C0012634 (UMLS CUI [2,4])
Carcinoma in situ of uterine cervix Treated | Disease Evidence of Lacking
Item
adequately treated cervical carcinoma in situ without evidence of disease
boolean
C0851140 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Prostatic Intraepithelial Neoplasias | Prostate carcinoma Evidence of Lacking
Item
prostatic intraepithelial neoplasia without evidence of prostate cancer
boolean
C0282612 (UMLS CUI [1])
C0600139 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
irinotecan
Item
prior irinotecan therapy
boolean
C0123931 (UMLS CUI [1])
Systemic Chemotherapy | Hormone Therapy | Immunotherapy
Item
systemic chemotherapy, hormonal therapy, or immunotherapy <= 21 days prior to randomization
boolean
C1883256 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Proteins | Antibodies | bevacizumab
Item
experimental or approved proteins/antibodies (eg, bevacizumab) <= 30 days prior to randomization
boolean
C0033684 (UMLS CUI [1])
C3495458 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
Heart Diseases | Myocardial Infarction | Angina, Unstable | Peripheral Vascular Diseases Grade | Cerebrovascular accident | Transient Ischemic Attack | Congestive heart failure | Cardiac Arrhythmia Uncontrolled | Percutaneous Transluminal Coronary Angioplasty | Stent
Item
clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0085096 (UMLS CUI [4,1])
C0441800 (UMLS CUI [4,2])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0018802 (UMLS CUI [7])
C0003811 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
C2936173 (UMLS CUI [9])
C0038257 (UMLS CUI [10])
Hypersensitivity irinotecan | Fluorouracil allergy | Dihydropyrimidine Dehydrogenase Deficiency | LEUCOVORIN ALLERGY
Item
known allergy or hypersensitivity to irinotecan, 5 fu (known dihydropyrimidine dehydrogenase deficiency) or leucovorin
boolean
C0020517 (UMLS CUI [1,1])
C0123931 (UMLS CUI [1,2])
C0570698 (UMLS CUI [2])
C1959620 (UMLS CUI [3])
C0745699 (UMLS CUI [4])
Inflammatory Bowel Diseases | Intestinal Diseases Causing Chronic diarrhea | Chronic diarrhea CTCAE Grades
Item
active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >= ctc grade 2 [ctcae version 3.0])
boolean
C0021390 (UMLS CUI [1])
C0021831 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0401151 (UMLS CUI [2,3])
C0401151 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])