ID

17928

Description

A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00091663

Link

https://clinicaltrials.gov/show/NCT00091663

Keywords

Versions (1)
  1. 10/10/16 10/10/16 -
Uploaded on

October 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Lung Cancer NCT00091663

English

Eligibility Lung Cancer NCT00091663

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written (signed) informed consent(s)
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
inoperable and incurable, locally advanced, recurrent or metastatic nsclc
Description

Non-Small Cell Lung Carcinoma Inoperable incurable | Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer recurrent | Non-small cell lung cancer metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205187
UMLS CUI [1,3]
C0175969
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [3]
C0278517
UMLS CUI [4]
C0278987
relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients)
Description

Chemotherapy | Relapse | Combination Chemotherapy | Combination Chemotherapy Pharmaceutical Preparations Two | Chemotherapy, single agent Patients Elderly | Chemotherapy, single agent Patients poor performance status

Data type

boolean

Alias
UMLS CUI [1]
C3665472
UMLS CUI [2]
C0035020
UMLS CUI [3]
C1521750
UMLS CUI [4,1]
C1521750
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0205448
UMLS CUI [5,1]
C3846440
UMLS CUI [5,2]
C0030705
UMLS CUI [5,3]
C0001792
UMLS CUI [6,1]
C3846440
UMLS CUI [6,2]
C0030705
UMLS CUI [6,3]
C1831741
age >=18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status of 0 to 3
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
recovered from the toxic effects of prior therapy
Description

Toxic effect Due to Prior Therapy | Patient Recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0521108
able to comply with study and follow-up procedures
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
able to take oral medication
Description

Able to take medication Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C4075001
UMLS CUI [1,2]
C1527415
use of an effective means of contraception (for patients with reproductive potential)
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
granulocyte count >=1.0 x 10^9/l
Description

Granulocyte count

Data type

boolean

Alias
UMLS CUI [1]
C0857490
platelet count >=75 x 10^9/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
serum bilirubin <1.5 x upper limit of normal (uln)
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
sgot (ast) <2 x uln unless elevation is clearly due to liver metastases; then sgot (ast) must be <5 x uln
Description

Aspartate aminotransferase measurement | Aspartate aminotransferase increased Due to Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2,1]
C0151904
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0494165
serum creatinine <=1.5 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease)
Description

Systemic disease Unstable | Communicable Diseases | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Liver diseases | Kidney Diseases | Metabolic Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0023895
UMLS CUI [7]
C0022658
UMLS CUI [8]
C0025517
prior therapy with any systemic her1/egfr small molecule inhibitor, including gefitinib (iressa), erlotinib (tarceva), or other investigational agents in this class
Description

HER1 Antagonists Small Molecule Systemic | gefitinib | Iressa | erlotinib | Tarceva | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C2916831
UMLS CUI [1,2]
C1328819
UMLS CUI [1,3]
C0205373
UMLS CUI [2]
C1122962
UMLS CUI [3]
C0919281
UMLS CUI [4]
C1135135
UMLS CUI [5]
C1135136
UMLS CUI [6]
C0013230
history of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of >=90%
Description

Malignant Neoplasm | Malignant Neoplasm Treated Adequate | Continuance of life Anticipated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205411
UMLS CUI [3,1]
C0038952
UMLS CUI [3,2]
C3840775
known central nervous system (cns) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable
Description

CNS metastases untreated | Operative Surgical Procedures | Therapeutic radiology procedure | CNS metastases Symptomatic | CNS metastases Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0543467
UMLS CUI [3]
C1522449
UMLS CUI [4,1]
C0686377
UMLS CUI [4,2]
C0231220
UMLS CUI [5,1]
C0686377
UMLS CUI [5,2]
C0443343
nursing mothers or pregnant females
Description

Breast Feeding | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
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Similar models

Eligibility Lung Cancer NCT00091663

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written (signed) informed consent(s)
boolean
C0021430 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma Inoperable incurable | Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer recurrent | Non-small cell lung cancer metastatic
Item
inoperable and incurable, locally advanced, recurrent or metastatic nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C0175969 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C0278517 (UMLS CUI [3])
C0278987 (UMLS CUI [4])
Chemotherapy | Relapse | Combination Chemotherapy | Combination Chemotherapy Pharmaceutical Preparations Two | Chemotherapy, single agent Patients Elderly | Chemotherapy, single agent Patients poor performance status
Item
relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients)
boolean
C3665472 (UMLS CUI [1])
C0035020 (UMLS CUI [2])
C1521750 (UMLS CUI [3])
C1521750 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0205448 (UMLS CUI [4,3])
C3846440 (UMLS CUI [5,1])
C0030705 (UMLS CUI [5,2])
C0001792 (UMLS CUI [5,3])
C3846440 (UMLS CUI [6,1])
C0030705 (UMLS CUI [6,2])
C1831741 (UMLS CUI [6,3])
Age
Item
age >=18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 to 3
boolean
C1520224 (UMLS CUI [1])
Toxic effect Due to Prior Therapy | Patient Recovered
Item
recovered from the toxic effects of prior therapy
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
Protocol Compliance
Item
able to comply with study and follow-up procedures
boolean
C0525058 (UMLS CUI [1])
Able to take medication Oral
Item
able to take oral medication
boolean
C4075001 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Fertility Contraceptive methods
Item
use of an effective means of contraception (for patients with reproductive potential)
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Granulocyte count
Item
granulocyte count >=1.0 x 10^9/l
boolean
C0857490 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >=75 x 10^9/l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin <1.5 x upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Aspartate aminotransferase increased Due to Secondary malignant neoplasm of liver
Item
sgot (ast) <2 x uln unless elevation is clearly due to liver metastases; then sgot (ast) must be <5 x uln
boolean
C0201899 (UMLS CUI [1])
C0151904 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0494165 (UMLS CUI [2,3])
Creatinine measurement, serum
Item
serum creatinine <=1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Systemic disease Unstable | Communicable Diseases | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Liver diseases | Kidney Diseases | Metabolic Diseases
Item
any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease)
boolean
C0442893 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
HER1 Antagonists Small Molecule Systemic | gefitinib | Iressa | erlotinib | Tarceva | Investigational New Drugs
Item
prior therapy with any systemic her1/egfr small molecule inhibitor, including gefitinib (iressa), erlotinib (tarceva), or other investigational agents in this class
boolean
C2916831 (UMLS CUI [1,1])
C1328819 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C1122962 (UMLS CUI [2])
C0919281 (UMLS CUI [3])
C1135135 (UMLS CUI [4])
C1135136 (UMLS CUI [5])
C0013230 (UMLS CUI [6])
Malignant Neoplasm | Malignant Neoplasm Treated Adequate | Continuance of life Anticipated
Item
history of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of >=90%
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0038952 (UMLS CUI [3,1])
C3840775 (UMLS CUI [3,2])
CNS metastases untreated | Operative Surgical Procedures | Therapeutic radiology procedure | CNS metastases Symptomatic | CNS metastases Unstable
Item
known central nervous system (cns) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0686377 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0686377 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
Breast Feeding | Pregnancy
Item
nursing mothers or pregnant females
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
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