ID

31746

Description

APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00652340

Link

https://clinicaltrials.gov/show/NCT00652340

Keywords

Versions (1)
  1. 9/25/18 9/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 25, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Recurrent Non Small Cell Lung Cancer NCT00652340

English

Eligibility Recurrent Non Small Cell Lung Cancer NCT00652340

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically determined stage iv nsclc including stage iiib (pleural effusion)
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural effusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0032227
failed at least one prior platinum-based chemotherapy for stage iiib or stage iv nsclc. patients receiving platinum-based chemotherapy only given in an adjuvant setting are not eligible.
Description

Chemotherapy Platinum-Based Quantity failed | Non-Small Cell Lung Carcinoma TNM clinical staging | Adjuvant Chemotherapy Platinum-Based Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514162
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0231175
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0085533
UMLS CUI [3,2]
C1514162
UMLS CUI [3,3]
C1512714
measurable disease by recist
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
greater than or equal to 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog ps of 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic investigational agents within 4 weeks of initiating study treatment
Description

Therapeutic radiology procedure | Chemotherapy | Investigational New Drugs | Exception Cytotoxic agent

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0304497
evidence of nyha class iii or greater cardiac disease
Description

Heart Disease New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
history of mi, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months
Description

Myocardial Infarction | Cerebrovascular accident | Ventricular arrhythmia | Cardiac conduction abnormality Symptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0085612
UMLS CUI [4,1]
C1842820
UMLS CUI [4,2]
C0231220
known hiv infection or aids
Description

HIV Infection | AIDS

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0001175
symptomatic cns metastases
Description

CNS metastases Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
pregnant or nursing women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other nsaids.
Description

Hypersensitivity Erlotinib | Intolerance to Erlotinib | Allergy to sulfonamides | Intolerance to Sulfonamides | Aspirin allergy | Intolerance to Aspirin | Allergy to nonsteroidal anti-inflammatory agents | Intolerance to NSAIDs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1135135
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1135135
UMLS CUI [3]
C0038757
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0038760
UMLS CUI [5]
C0004058
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0004057
UMLS CUI [7]
C0746949
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0003211
history of upper gi bleeding, ulceration, or perforation
Description

Upper gastrointestinal hemorrhage | Upper Gastrointestinal Tract Ulceration | Upper gastrointestinal perforation

Data type

boolean

Alias
UMLS CUI [1]
C0041909
UMLS CUI [2,1]
C3203348
UMLS CUI [2,2]
C3887532
UMLS CUI [3]
C0749862
prior history of cox-2 inhibitor therapy for the treatment of metastatic nsclc
Description

Cyclooxygenase 2 Inhibitors | Therapeutic procedure Non-small cell lung cancer metastatic

Data type

boolean

Alias
UMLS CUI [1]
C1257954
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0278987
previous anti-egfr kinase therapy
Description

EGFR Tyrosine Kinase Inhibitor Therapy

Data type

boolean

Alias
UMLS CUI [1]
C3899317
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Similar models

Eligibility Recurrent Non Small Cell Lung Cancer NCT00652340

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural effusion
Item
pathologically determined stage iv nsclc including stage iiib (pleural effusion)
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
Chemotherapy Platinum-Based Quantity failed | Non-Small Cell Lung Carcinoma TNM clinical staging | Adjuvant Chemotherapy Platinum-Based Ineligible
Item
failed at least one prior platinum-based chemotherapy for stage iiib or stage iv nsclc. patients receiving platinum-based chemotherapy only given in an adjuvant setting are not eligible.
boolean
C0392920 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3,1])
C1514162 (UMLS CUI [3,2])
C1512714 (UMLS CUI [3,3])
Measurable Disease
Item
measurable disease by recist
boolean
C1513041 (UMLS CUI [1])
Age
Item
greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog ps of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Chemotherapy | Investigational New Drugs | Exception Cytotoxic agent
Item
radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic investigational agents within 4 weeks of initiating study treatment
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0304497 (UMLS CUI [4,2])
Heart Disease New York Heart Association Classification
Item
evidence of nyha class iii or greater cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction | Cerebrovascular accident | Ventricular arrhythmia | Cardiac conduction abnormality Symptomatic
Item
history of mi, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0085612 (UMLS CUI [3])
C1842820 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
HIV Infection | AIDS
Item
known hiv infection or aids
boolean
C0019693 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
CNS metastases Symptomatic
Item
symptomatic cns metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Erlotinib | Intolerance to Erlotinib | Allergy to sulfonamides | Intolerance to Sulfonamides | Aspirin allergy | Intolerance to Aspirin | Allergy to nonsteroidal anti-inflammatory agents | Intolerance to NSAIDs
Item
hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other nsaids.
boolean
C0020517 (UMLS CUI [1,1])
C1135135 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1135135 (UMLS CUI [2,2])
C0038757 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0038760 (UMLS CUI [4,2])
C0004058 (UMLS CUI [5])
C1744706 (UMLS CUI [6,1])
C0004057 (UMLS CUI [6,2])
C0746949 (UMLS CUI [7])
C1744706 (UMLS CUI [8,1])
C0003211 (UMLS CUI [8,2])
Upper gastrointestinal hemorrhage | Upper Gastrointestinal Tract Ulceration | Upper gastrointestinal perforation
Item
history of upper gi bleeding, ulceration, or perforation
boolean
C0041909 (UMLS CUI [1])
C3203348 (UMLS CUI [2,1])
C3887532 (UMLS CUI [2,2])
C0749862 (UMLS CUI [3])
Cyclooxygenase 2 Inhibitors | Therapeutic procedure Non-small cell lung cancer metastatic
Item
prior history of cox-2 inhibitor therapy for the treatment of metastatic nsclc
boolean
C1257954 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0278987 (UMLS CUI [2,2])
EGFR Tyrosine Kinase Inhibitor Therapy
Item
previous anti-egfr kinase therapy
boolean
C3899317 (UMLS CUI [1])
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