ID

22150

Description

Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00694603

Link

https://clinicaltrials.gov/show/NCT00694603

Keywords

Versions (1)
  1. 5/21/17 5/21/17 -
Uploaded on

May 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00694603

English

Eligibility Non-small Cell Lung Cancer NCT00694603

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically confirmed stage iiib or iv recurrent or progressive nsclc
Description

nsclc stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0178759
patients must have progressed while receiving treatment with a tyrosine kinase inhibitor targeting the egfr pathway
Description

disease progression while egfr tyrosine kinase inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C1443775
measurable disease, as defined by recist criteria
Description

recist criteria

Data type

boolean

Alias
UMLS CUI [1]
C1709926
patients must have a suitable frozen or paraffin-embedded tissue sample available for egfr mutational analysis. prior egfr mutational analyses are allowable
Description

egfr mutational status

Data type

boolean

Alias
UMLS CUI [1]
C3266973
patients with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be clinically stable
Description

asymptomatic brain metastasis, radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231221
UMLS CUI [1,3]
C1522449
ecog performance status 0-2
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
18 years of age or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
negative pregnancy test within 7 days of treatment or be categorized as not of child-bearing potential
Description

pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032976
bone marrow function, renal function, hepatic function as outlined in protocol
Description

bone marrow, renal, hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0005953
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant of breastfeeding
Description

pregnancy, breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
active concurrent malignancy
Description

concurrent malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
major thoracic or abdominal surgery within 30 days prior to the first infusion of cetuximab
Description

major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
significant history of uncontrolled cardiac disease
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
uncontrolled seizure disorder, or active neurological disease
Description

seizure disorder, neurological disease

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0027765
prior severe infusion reactions to a monoclonal antibody
Description

monoclonal antibodies adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0003250
UMLS CUI [1,2]
C0877248
prior chemotherapy regimen within 21 days prior to study entry
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
any egfr tyrosine kinase inhibitor within 14 days of study entry
Description

egfr tyrosine kinase inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1443775
radiation therapy within 14 days prior to the first infusion of cetuximab
Description

radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
acute hepatitis or known hiv
Description

acute hepatitis, hiv

Data type

boolean

Alias
UMLS CUI [1]
C0267797
UMLS CUI [2]
C0019682
active or uncontrolled infection
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
any concurrent chemotherapy or any other investigational agent(s)
Description

concurrent chemotherapy, investigational agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0009429
UMLS CUI [2]
C0013230
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00694603

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
nsclc stage
Item
pathologically confirmed stage iiib or iv recurrent or progressive nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0178759 (UMLS CUI [1,2])
disease progression while egfr tyrosine kinase inhibitor
Item
patients must have progressed while receiving treatment with a tyrosine kinase inhibitor targeting the egfr pathway
boolean
C0242656 (UMLS CUI [1,1])
C1443775 (UMLS CUI [1,2])
recist criteria
Item
measurable disease, as defined by recist criteria
boolean
C1709926 (UMLS CUI [1])
egfr mutational status
Item
patients must have a suitable frozen or paraffin-embedded tissue sample available for egfr mutational analysis. prior egfr mutational analyses are allowable
boolean
C3266973 (UMLS CUI [1])
asymptomatic brain metastasis, radiotherapy
Item
patients with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be clinically stable
boolean
C0220650 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
ecog
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
pregnancy test
Item
negative pregnancy test within 7 days of treatment or be categorized as not of child-bearing potential
boolean
C0032976 (UMLS CUI [1])
bone marrow, renal, hepatic function
Item
bone marrow function, renal function, hepatic function as outlined in protocol
boolean
C0005953 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
pregnancy, breast feeding
Item
women who are pregnant of breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
concurrent malignancy
Item
active concurrent malignancy
boolean
C0006826 (UMLS CUI [1])
major surgery
Item
major thoracic or abdominal surgery within 30 days prior to the first infusion of cetuximab
boolean
C0679637 (UMLS CUI [1])
cardiac disease
Item
significant history of uncontrolled cardiac disease
boolean
C0018799 (UMLS CUI [1])
seizure disorder, neurological disease
Item
uncontrolled seizure disorder, or active neurological disease
boolean
C0014544 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
monoclonal antibodies adverse event
Item
prior severe infusion reactions to a monoclonal antibody
boolean
C0003250 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
chemotherapy
Item
prior chemotherapy regimen within 21 days prior to study entry
boolean
C0392920 (UMLS CUI [1])
egfr tyrosine kinase inhibitors
Item
any egfr tyrosine kinase inhibitor within 14 days of study entry
boolean
C1443775 (UMLS CUI [1])
radiotherapy
Item
radiation therapy within 14 days prior to the first infusion of cetuximab
boolean
C1522449 (UMLS CUI [1])
acute hepatitis, hiv
Item
acute hepatitis or known hiv
boolean
C0267797 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
infection
Item
active or uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
concurrent chemotherapy, investigational agents
Item
any concurrent chemotherapy or any other investigational agent(s)
boolean
C0392920 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
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