Colon Carcinoma metastatic | Colon Carcinoma unresectable
Item
histologically confirmed colon cancer that is metastatic or unresectable
boolean
C0699790 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0699790 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
Disease Progression | Combined Modality Therapy | cetuximab | irinotecan
Item
progressed on cetuximab plus irinotecan based combination prior to enrolling on this study
boolean
C0242656 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0995188 (UMLS CUI [3])
C0123931 (UMLS CUI [4])
Tumor tissue sample KRAS Mutation Analysis | KRAS gene Wild Type
Item
patient must have tumor tissue tested for kras mutation and should be confirmed to carry a wild type
boolean
C0475358 (UMLS CUI [1,1])
C2697836 (UMLS CUI [1,2])
C1537502 (UMLS CUI [2,1])
C1883559 (UMLS CUI [2,2])
ECOG performance status
Item
ecog less than or equal to 1
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
must have adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Measurable Disease | Lesion size CT | Lesion size Spiral CT
Item
presence of measurable disease defined as a lesion ≥ 2 cm by ct (or 1 cm by spiral ct). all sites of disease should be evaluated ≤ 3 weeks before treatment initiation
boolean
C1513041 (UMLS CUI [1])
C0449453 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0449453 (UMLS CUI [3,1])
C0860888 (UMLS CUI [3,2])
Chemotherapy failed | Intolerance Chemotherapy | oxaliplatin | fluoropyrimidine
Item
patients should have failed or been deemed intolerant to other standard chemotherapy treatments such as oxaliplatin and fluoropyrimidines
boolean
C0392920 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231199 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0069717 (UMLS CUI [3])
C0596581 (UMLS CUI [4])
Investigational New Drugs Other | Antineoplastic Agents Investigational | Herbal medicine allowed | Vitamins allowed
Item
patients may not be receiving any other investigational agents that are not included in this study. prior investigational anticancer agents wil not be allowed within 4 weeks prior to study treatment. herbal medicine and vitamins wil not be considered as contraindications for enrollment on study.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0003392 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C2240391 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0042890 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain | Exception Metastatic malignant neoplasm to brain Treated Stable | Exception Symptoms Free of
Item
patients with known brain metastases are not eligible unless brain metastases are treated and stable on radiographic follow-up and without significant symptomatology
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Invasive cancer Other
Item
history of other invasive cancers with current evidence of disease
boolean
C0677898 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Chemotherapy Discontinued | Targeted Therapy Discontinued | Mitomycin Discontinued
Item
patients should be off chemotherapy or other targeted therapies for at least 3 weeks before study treatment. mitomycin c treatment should be at least 6 weeks before study treatment
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0002475 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Allergic Reaction irinotecan
Item
history of allergic reactions to irinotecan
boolean
C1527304 (UMLS CUI [1,1])
C0123931 (UMLS CUI [1,2])
Infusion reaction Severe Cetuximab
Item
prior severe infusion reaction to cetuximab
boolean
C2368034 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0995188 (UMLS CUI [1,3])
Tetracycline allergy | Doxycycline allergy
Item
history of allergic reaction to tetracycline or doxycycline
boolean
C0039645 (UMLS CUI [1])
C0571496 (UMLS CUI [2])
Cetuximab Dose Reduction Patient need for | Dose Reduction Secondary to Skin toxicity CTCAE Grades
Item
need for prior dose reduction on cetuximab secondary to grade 3 skin toxicity
boolean
C0995188 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392756 (UMLS CUI [1,3])
C0686904 (UMLS CUI [1,4])
C0178602 (UMLS CUI [2,1])
C0392756 (UMLS CUI [2,2])
C0175668 (UMLS CUI [2,3])
C1167791 (UMLS CUI [2,4])
C1516728 (UMLS CUI [2,5])
Skin toxicity CTCAE Grades
Item
active skin toxicity of grade 2 or higher at the time of study enrollment
boolean
C1167791 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Communicable Disease | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0525058 (UMLS CUI [5,2])
C0439801 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
Pregnancy | Breast Feeding To be stopped | Chemotherapeutic agent At risk Teratogenic effect | Chemotherapeutic agent At risk Abortifacient Effect
Item
pregnant women are excluded from this study because the chemotherapeutic agents proposed are category d agents with the potential for teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued if the mother is treated on this study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0729502 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0232910 (UMLS CUI [3,3])
C0729502 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C3179338 (UMLS CUI [4,3])
Hypomagnesemia Grade
Item
grade 2 or higher hypomagnesemia at baseline evaluation
boolean
C0151723 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])