ID

28306

Description

Cetuximab Plus Irinotecan in Colorectal Cancer Patients Who Progressed After Failure With Cetuximab Plus Irinotecan; ODM derived from: https://clinicaltrials.gov/show/NCT01004159

Link

https://clinicaltrials.gov/show/NCT01004159

Keywords

Versions (1)
  1. 1/3/18 1/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT01004159

English

Eligibility Colorectal Cancer NCT01004159

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed colon cancer that is metastatic or unresectable
Description

Colon Carcinoma metastatic | Colon Carcinoma unresectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0699790
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C0699790
UMLS CUI [2,2]
C1519810
progressed on cetuximab plus irinotecan based combination prior to enrolling on this study
Description

Disease Progression | Combined Modality Therapy | cetuximab | irinotecan

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0995188
UMLS CUI [4]
C0123931
patient must have tumor tissue tested for kras mutation and should be confirmed to carry a wild type
Description

Tumor tissue sample KRAS Mutation Analysis | KRAS gene Wild Type

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C2697836
UMLS CUI [2,1]
C1537502
UMLS CUI [2,2]
C1883559
ecog less than or equal to 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
must have adequate organ and marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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
Description

Measurable Disease | Lesion size CT | Lesion size Spiral CT

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0449453
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C0449453
UMLS CUI [3,2]
C0860888
patients should have failed or been deemed intolerant to other standard chemotherapy treatments such as oxaliplatin and fluoropyrimidines
Description

Chemotherapy failed | Intolerance Chemotherapy | oxaliplatin | fluoropyrimidine

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0231199
UMLS CUI [2,2]
C0392920
UMLS CUI [3]
C0069717
UMLS CUI [4]
C0596581
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Description

Investigational New Drugs Other | Antineoplastic Agents Investigational | Herbal medicine allowed | Vitamins allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0003392
UMLS CUI [2,2]
C1517586
UMLS CUI [3,1]
C2240391
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0042890
UMLS CUI [4,2]
C0683607
patients with known brain metastases are not eligible unless brain metastases are treated and stable on radiographic follow-up and without significant symptomatology
Description

Metastatic malignant neoplasm to brain | Exception Metastatic malignant neoplasm to brain Treated Stable | Exception Symptoms Free of

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220650
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C0205360
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1457887
UMLS CUI [3,3]
C0332296
history of other invasive cancers with current evidence of disease
Description

Invasive cancer Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C0205394
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
Description

Chemotherapy Discontinued | Targeted Therapy Discontinued | Mitomycin Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0002475
UMLS CUI [3,2]
C1444662
history of allergic reactions to irinotecan
Description

Allergic Reaction irinotecan

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0123931
prior severe infusion reaction to cetuximab
Description

Infusion reaction Severe Cetuximab

Data type

boolean

Alias
UMLS CUI [1,1]
C2368034
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0995188
history of allergic reaction to tetracycline or doxycycline
Description

Tetracycline allergy | Doxycycline allergy

Data type

boolean

Alias
UMLS CUI [1]
C0039645
UMLS CUI [2]
C0571496
need for prior dose reduction on cetuximab secondary to grade 3 skin toxicity
Description

Cetuximab Dose Reduction Patient need for | Dose Reduction Secondary to Skin toxicity CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0995188
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0392756
UMLS CUI [1,4]
C0686904
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0392756
UMLS CUI [2,3]
C0175668
UMLS CUI [2,4]
C1167791
UMLS CUI [2,5]
C1516728
active skin toxicity of grade 2 or higher at the time of study enrollment
Description

Skin toxicity CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C1167791
UMLS CUI [1,2]
C1516728
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.
Description

Comorbidity Uncontrolled | Communicable Disease | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0003811
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0525058
UMLS CUI [5,3]
C0439801
UMLS CUI [6,1]
C0748872
UMLS CUI [6,2]
C0525058
UMLS CUI [6,3]
C0439801
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.
Description

Pregnancy | Breast Feeding To be stopped | Chemotherapeutic agent At risk Teratogenic effect | Chemotherapeutic agent At risk Abortifacient Effect

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1272691
UMLS CUI [3,1]
C0729502
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0232910
UMLS CUI [4,1]
C0729502
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C3179338
grade 2 or higher hypomagnesemia at baseline evaluation
Description

Hypomagnesemia Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0151723
UMLS CUI [1,2]
C0441800
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Similar models

Eligibility Colorectal Cancer NCT01004159

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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