ID

27488

Description

2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00835471

Link

https://clinicaltrials.gov/show/NCT00835471

Keywords

Versions (1)
  1. 11/16/17 11/16/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 16, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT00835471

English

Eligibility Carcinoma, Non-Small-Cell Lung NCT00835471

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed nsclc, locally advanced and metastatic disease stage iiib and iv. evidence of disease progression after one or two cytotoxic treatment regimens which should have included a platinum agent.
Description

Non-Small Cell Lung Carcinoma Advanced Local TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | Cytotoxic Chemotherapy Quantity | Platinum-based Drug | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0677881
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C2266918
UMLS CUI [5]
C0242656
2. complete recovery from prior chemotherapy side effects to < grade 2.
Description

Adverse effects Due to Prior Chemotherapy | Complete Recovery CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0879626
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514457
UMLS CUI [2,1]
C2826210
UMLS CUI [2,2]
C1516728
3. at least one unidimensional measurable lesion meeting recist criteria.
Description

Measurable lesion Linear Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
4. ecog ps 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. age > 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
6. adequate organ function, including:
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
adequate bone marrow reserve: anc > 1.5 x 109/l, platelets > 100 x 109/l.
Description

Mature Neutrophils Present Bone Marrow Adequate | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1708947
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0205411
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
hepatic: bilirubin <1.5 x uln, ap, alt, ast < 1.5 x uln ap, alt, and ast <5 x uln is acceptable if the liver has tumor involvement
Description

Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Involvement with Tumor

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201850
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
UMLS CUI [6,1]
C0023884
UMLS CUI [6,2]
C1314939
UMLS CUI [6,3]
C0027651
renal: calculated creatinin clearance > 40 ml/min based on the cockcroft-gault formula.
Description

Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C2711451
7. estimated life expectancy >12 weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
8. male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Description

Reproductive potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
9. signed informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
10. patient compliance and geographical proximity that allow adequate follow up.
Description

Compliance behavior allowing Follow-up | Proximity Geographic allowing Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C3274571
UMLS CUI [2,1]
C1514583
UMLS CUI [2,2]
C1517526
UMLS CUI [2,3]
C0683607
UMLS CUI [2,4]
C3274571
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
Description

Risk Medical Due to Disease | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0012634
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
3. documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment.
Description

Metastatic malignant neoplasm to brain | Exception Local Therapy Complete CNS metastases | Exception Adrenal Cortex Hormones Discontinued

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1517925
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C0686377
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0001617
UMLS CUI [3,3]
C1444662
4. previous treatment with an egfr-tki, or in non-squamous histology earlier treatment with pemetrexed and in squamous earlier treatment with docetaxel.
Description

Epidermal Growth Factor Receptor | pemetrexed | docetaxel

Data type

boolean

Alias
UMLS CUI [1]
C0034802
UMLS CUI [2]
C0210657
UMLS CUI [3]
C0246415
5. inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (5 day period for long-acting agents such as piroxicam).
Description

Aspirin Unable to discontinue | NSAIDs Unable to discontinue | Piroxicam Unable to discontinue

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C1548265
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1548265
UMLS CUI [3,1]
C0031990
UMLS CUI [3,2]
C1548265
6. inability or unwillingness to take folic acid, vitamin b-12 supplementation or dexamethasone.
Description

Folic acid supplementation Intake Unable | Folic acid supplementation Intake Unwilling | Vitamin B12 supplement Intake Unable | Vitamin B12 supplement Intake Unwilling | Dexamethasone Intake Unable | Dexamethasone Intake Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0556110
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0556110
UMLS CUI [2,2]
C1512806
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C3661610
UMLS CUI [3,2]
C1512806
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C3661610
UMLS CUI [4,2]
C1512806
UMLS CUI [4,3]
C0558080
UMLS CUI [5,1]
C0011777
UMLS CUI [5,2]
C1512806
UMLS CUI [5,3]
C1299582
UMLS CUI [6,1]
C0011777
UMLS CUI [6,2]
C1512806
UMLS CUI [6,3]
C0558080
7. concomitant treatment with any other experimental drug under investigation.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT00835471

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Local TNM clinical staging | Non-small cell lung cancer metastatic TNM clinical staging | Cytotoxic Chemotherapy Quantity | Platinum-based Drug | Disease Progression
Item
1. histologically or cytologically confirmed nsclc, locally advanced and metastatic disease stage iiib and iv. evidence of disease progression after one or two cytotoxic treatment regimens which should have included a platinum agent.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0278987 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0677881 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C2266918 (UMLS CUI [4])
C0242656 (UMLS CUI [5])
Adverse effects Due to Prior Chemotherapy | Complete Recovery CTCAE Grades
Item
2. complete recovery from prior chemotherapy side effects to < grade 2.
boolean
C0879626 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514457 (UMLS CUI [1,3])
C2826210 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Measurable lesion Linear Quantity
Item
3. at least one unidimensional measurable lesion meeting recist criteria.
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECOG performance status
Item
4. ecog ps 0-2.
boolean
C1520224 (UMLS CUI [1])
Age
Item
5. age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Organ function
Item
6. adequate organ function, including:
boolean
C0678852 (UMLS CUI [1])
Mature Neutrophils Present Bone Marrow Adequate | Absolute neutrophil count | Platelet Count measurement
Item
adequate bone marrow reserve: anc > 1.5 x 109/l, platelets > 100 x 109/l.
boolean
C1708947 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Alkaline phosphatase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Liver Involvement with Tumor
Item
hepatic: bilirubin <1.5 x uln, ap, alt, ast < 1.5 x uln ap, alt, and ast <5 x uln is acceptable if the liver has tumor involvement
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0023884 (UMLS CUI [6,1])
C1314939 (UMLS CUI [6,2])
C0027651 (UMLS CUI [6,3])
Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
renal: calculated creatinin clearance > 40 ml/min based on the cockcroft-gault formula.
boolean
C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Life Expectancy
Item
7. estimated life expectancy >12 weeks.
boolean
C0023671 (UMLS CUI [1])
Reproductive potential Contraceptive methods | Childbearing Potential Serum pregnancy test negative
Item
8. male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Informed Consent
Item
9. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Compliance behavior allowing Follow-up | Proximity Geographic allowing Follow-up
Item
10. patient compliance and geographical proximity that allow adequate follow up.
boolean
C1321605 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C1514583 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C3274571 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Risk Medical Due to Disease | Communicable Disease Uncontrolled
Item
2. patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
boolean
C0035647 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain | Exception Local Therapy Complete CNS metastases | Exception Adrenal Cortex Hormones Discontinued
Item
3. documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment.
boolean
C0220650 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1517925 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0686377 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
Epidermal Growth Factor Receptor | pemetrexed | docetaxel
Item
4. previous treatment with an egfr-tki, or in non-squamous histology earlier treatment with pemetrexed and in squamous earlier treatment with docetaxel.
boolean
C0034802 (UMLS CUI [1])
C0210657 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
Aspirin Unable to discontinue | NSAIDs Unable to discontinue | Piroxicam Unable to discontinue
Item
5. inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (5 day period for long-acting agents such as piroxicam).
boolean
C0004057 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
C0031990 (UMLS CUI [3,1])
C1548265 (UMLS CUI [3,2])
Folic acid supplementation Intake Unable | Folic acid supplementation Intake Unwilling | Vitamin B12 supplement Intake Unable | Vitamin B12 supplement Intake Unwilling | Dexamethasone Intake Unable | Dexamethasone Intake Unwilling
Item
6. inability or unwillingness to take folic acid, vitamin b-12 supplementation or dexamethasone.
boolean
C0556110 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0556110 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C3661610 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C3661610 (UMLS CUI [4,1])
C1512806 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
C0011777 (UMLS CUI [5,1])
C1512806 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C0011777 (UMLS CUI [6,1])
C1512806 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
Investigational New Drugs
Item
7. concomitant treatment with any other experimental drug under investigation.
boolean
C0013230 (UMLS CUI [1])
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