Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic
Item
diagnosis of metastatic adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Tumor tissue sample Paraffin Embedding Available
Item
available paraffin-embedded tumor tissue
boolean
C0475358 (UMLS CUI [1,1])
C0085185 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Colorectal Carcinoma metastatic | First line treatment fluoropyrimidine failed | Chemotherapy oxaliplatin failed | Chemotherapy bevacizumab failed
Item
failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mcrc
boolean
C0009402 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C1708063 (UMLS CUI [2,1])
C0596581 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C0069717 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0796392 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Metabolic function normal
Item
adequate hematologic, renal, hepatic and metabolic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0438212 (UMLS CUI [4])
Therapeutic radiology procedure
Item
radiotherapy ≤ 2 weeks prior to day 1 of cycle 1
boolean
C1522449 (UMLS CUI [1])
cancer treatment | Toxic effect resolution | Study Subject Participation Status Exclusion
Item
unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
boolean
C0920425 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
irinotecan Colorectal Carcinoma metastatic | EGFR Antibody Colorectal Carcinoma metastatic | Vaccines Colorectal Carcinoma metastatic
Item
prior irinotecan therapy. anti egfr therapy, or vaccine for the treatment of mcrc
boolean
C0123931 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
C1522484 (UMLS CUI [1,3])
C4055105 (UMLS CUI [2,1])
C0009402 (UMLS CUI [2,2])
C1522484 (UMLS CUI [2,3])
C0042210 (UMLS CUI [3,1])
C0009402 (UMLS CUI [3,2])
C1522484 (UMLS CUI [3,3])
CYP3A4 Inducers | CYP3A4 Inhibitors | CYP3A4 Substrate | Phenytoin | Phenobarbital | Carbamazepine | Ketoconazole | Rifampin | Rifabutin | Hypericum perforatum
Item
cyp3a4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and st. john's wort) ≤ 2 weeks prior to day 1 of cycle 1
boolean
C3850041 (UMLS CUI [1])
C3850053 (UMLS CUI [2])
C3714798 (UMLS CUI [3,1])
C3891814 (UMLS CUI [3,2])
C0031507 (UMLS CUI [4])
C0031412 (UMLS CUI [5])
C0006949 (UMLS CUI [6])
C0022625 (UMLS CUI [7])
C0035608 (UMLS CUI [8])
C0140575 (UMLS CUI [9])
C0936242 (UMLS CUI [10])
Communicable Disease Requirement ANTIINFECTIVES FOR SYSTEMIC USE
Item
infection requiring systemic anti infectives completed ≤ 2 weeks prior to day 1 of cycle 1
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C3653775 (UMLS CUI [1,3])
Cardiovascular Disease
Item
clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Lung Diseases, Interstitial | Pneumonitis | Pulmonary Fibrosis
Item
history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
boolean
C0206062 (UMLS CUI [1])
C3714636 (UMLS CUI [2])
C0034069 (UMLS CUI [3])
Pulmonary Embolism | Deep Vein Thrombosis | Thromboembolism
Item
pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤
boolean
C0034065 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0040038 (UMLS CUI [3])
ID.14
Item
8 weeks prior to day 1 of cycle 1
boolean
Hemorrhage
Item
any significant bleeding ≤6 weeks prior to day 1 of cycle 1, per the investigator's judgement
boolean
C0019080 (UMLS CUI [1])
Peptic Ulcer Endoscopy | Gastrointestinal ulcer | Gastrointestinal ulcer Uncontrolled
Item
gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to day1 of cycle 1
boolean
C0030920 (UMLS CUI [1,1])
C0014245 (UMLS CUI [1,2])
C0237938 (UMLS CUI [2])
C0237938 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Comorbidity Risk Increase Toxic effect | Condition Risk Increase Toxic effect | Dihydropyrimidine Dehydrogenase Deficiency | Ascites | Pleural effusion
Item
any co morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
boolean
C0009488 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0442805 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0442805 (UMLS CUI [2,3])
C0600688 (UMLS CUI [2,4])
C1959620 (UMLS CUI [3])
C0003962 (UMLS CUI [4])
C0032227 (UMLS CUI [5])
Major surgery Requirement General Anesthesia | Incisional biopsy | Traumatic injury | Operative Surgical Procedures Recovered | Complication Absent
Item
major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤4 weeks prior to day1 of cycle 1. subjects must have recovered from surgery and have no significant complications
boolean
C0679637 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0002915 (UMLS CUI [1,3])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C0521108 (UMLS CUI [4,2])
C0009566 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])