COLON ADENOCARCINOMA METASTATIC | Adenocarcinoma of rectum metastatic
Item
diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum.
boolean
C0742581 (UMLS CUI [1])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Measurable Disease
Item
measurable disease according to modified recist guidelines.
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Primary tumor Paraffin Embedded Tissue Available | Neoplasm Metastasis Paraffin Embedded Tissue Available | Primary tumor Unstained Specimen Available | Neoplasm Metastasis Unstained Specimen Available
Item
paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour available for central lab analysis.
boolean
C0677930 (UMLS CUI [1,1])
C1519524 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C1519524 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
C0677930 (UMLS CUI [3,1])
C1883469 (UMLS CUI [3,2])
C0470187 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C1883469 (UMLS CUI [4,2])
C0470187 (UMLS CUI [4,3])
Hematologic function | Renal function | Liver function | Metabolic function normal
Item
adequate haematologic, renal, hepatic and metabolic function.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0438212 (UMLS CUI [4])
CNS metastases
Item
central nervous system metastases.
boolean
C0686377 (UMLS CUI [1])
Systemic therapy Colorectal cancer metastatic | Exception Adjuvant Chemotherapy Fluoropyrimidine
Item
prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment.
boolean
C1515119 (UMLS CUI [1,1])
C0948380 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0085533 (UMLS CUI [2,2])
C0596581 (UMLS CUI [2,3])
EGFR Antibody Therapeutic procedure | cetuximab | Small Molecule EGFR Tyrosine Kinase Inhibitor Therapy | erlotinib
Item
prior anti-egfr antibody therapy (e.g.: cetuximab) or treatment with small molecule egfr tyrosine kinase inhibitors (e.g.: erlotinib).
boolean
C4055105 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0995188 (UMLS CUI [2])
C1328819 (UMLS CUI [3,1])
C3899317 (UMLS CUI [3,2])
C1135135 (UMLS CUI [4])
Therapeutic radiology procedure | Toxicity Signs Abate Lacking
Item
prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated.
boolean
C1522449 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0311392 (UMLS CUI [2,2])
C3853704 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
Cardiovascular Diseases | Angina, Unstable | Myocardial Infarction | Ventricular arrhythmia
Item
significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia.
boolean
C0007222 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0085612 (UMLS CUI [4])
Interstitial Pneumonitis | Pulmonary Fibrosis | Chest CT
Item
history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest ct scan.
boolean
C0206061 (UMLS CUI [1])
C0034069 (UMLS CUI [2])
C0202823 (UMLS CUI [3])
Inflammatory Bowel Disease Causing Chronic diarrhea | Intestinal Disease Causing Chronic diarrhea | Loose stool Quantity per day
Item
active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
boolean
C0021390 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0401151 (UMLS CUI [1,3])
C0021831 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0401151 (UMLS CUI [2,3])
C2129214 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0439505 (UMLS CUI [3,3])
Gilbert Disease | Dihydropyrimidine Dehydrogenase Deficiency
Item
history of gilbert's syndrome or dihydropyrimidine deficiency.
boolean
C0017551 (UMLS CUI [1])
C1959620 (UMLS CUI [2])
HIV Seropositivity | Hepatitis C positive | Chronic active hepatitis B
Item
known positive test for human immunodeficiency virus infection, hepatitis c virus, chronic active hepatitis b infection.
boolean
C0019699 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0744831 (UMLS CUI [3])
Investigational New Drugs
Item
any investigational agent within 30 days before initiation of study treatment.
boolean
C0013230 (UMLS CUI [1])
major surgery
Item
must not have had a major surgical procedure within 28 days prior to initiation of study treatment.
boolean
C0679637 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
subject who is pregnant or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling | Gender
Item
woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for six months after the last study drug administration for women, and one month for men.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol specified criteria and specific details may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])