ID

15843

Description

Ph II OSI-774 (Erlotinib,Tarceva) In Advanced Bronchioloalveolar Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00590902

Link

https://clinicaltrials.gov/show/NCT00590902

Keywords

Versions (1)
  1. 6/15/16 6/15/16 -
Uploaded on

June 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer NCT00590902

English

Eligibility Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer NCT00590902

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
either bronchioloalveolar cell carcinoma or a variant thereof after review
Description

bronchioloalveolar cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007120
clinical stage iiib (malignant pleural or pericardial effusion) or iv or recurrent/medically inoperable disease
Description

clinical stage iiib

Data type

boolean

Alias
UMLS CUI [1]
C0205580
UMLS CUI [2]
C0205585
measurable or evaluable indicator lesions
Description

evaluable indicator lesions

Data type

boolean

Alias
UMLS CUI [1]
C1513041
no prior or one chemotherapy regimen for nsclc
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0007131
three weeks since last chemotherapy, and three weeks since prior radiation therapy to a major bone-marrow containing area
Description

therapeutic procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C1522449
UMLS CUI [2]
C0392920
karnofsky performance status > or = to 80% or ecog performance status ≤ or = to 1
Description

karnofsky performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
life expectancy > or = to 8 weeks
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
adequate hematologic, renal and/or hepatic function: wbc > or = to 3,000/ul, hemoglobin > or = to 9.0 g/dl, platelet count > or = to 100,000/ul, total bilirubin < or = to 1.0 mg/dl, ast < than or = to 2.5 x unl, creatinine < or = to 1.5 mg/dl or clcr > or = to 55ml/min.
Description

lab tests

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0005821
UMLS CUI [4]
C0201913
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0373595
effective contraception
Description

effective contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure to osi-774 or other treatments targeting the her family axis (e.g.-trastuzumab, zd1839, c225, etc.)
Description

exposure to osi-774

Data type

boolean

Alias
UMLS CUI [1,1]
C1135137
UMLS CUI [1,2]
C0332157
two or more prior chemotherapy regimens
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0449788
concurrent active cancer
Description

active cancer

Data type

boolean

Alias
UMLS CUI [1]
C0006826
uncontrolled central nervous system metastases (i.e. any known cns lesion which is radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids)
Description

central nervous system metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
pregnant or lactating women
Description

pregnancy or lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
Description

malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
prior systemic cytotoxic chemotherapy for other malignant disease
Description

systemic cytotoxic chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0677881
significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure, recent mi, unstable angina, active infection, uncontrolled hypertension).
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
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Similar models

Eligibility Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer NCT00590902

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
bronchioloalveolar cell carcinoma
Item
either bronchioloalveolar cell carcinoma or a variant thereof after review
boolean
C0007120 (UMLS CUI [1])
clinical stage iiib
Item
clinical stage iiib (malignant pleural or pericardial effusion) or iv or recurrent/medically inoperable disease
boolean
C0205580 (UMLS CUI [1])
C0205585 (UMLS CUI [2])
evaluable indicator lesions
Item
measurable or evaluable indicator lesions
boolean
C1513041 (UMLS CUI [1])
chemotherapy
Item
no prior or one chemotherapy regimen for nsclc
boolean
C0392920 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
therapeutic procedures
Item
three weeks since last chemotherapy, and three weeks since prior radiation therapy to a major bone-marrow containing area
boolean
C0005953 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
karnofsky performance status
Item
karnofsky performance status > or = to 80% or ecog performance status ≤ or = to 1
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
life expectancy
Item
life expectancy > or = to 8 weeks
boolean
C0023671 (UMLS CUI [1])
lab tests
Item
adequate hematologic, renal and/or hepatic function: wbc > or = to 3,000/ul, hemoglobin > or = to 9.0 g/dl, platelet count > or = to 100,000/ul, total bilirubin < or = to 1.0 mg/dl, ast < than or = to 2.5 x unl, creatinine < or = to 1.5 mg/dl or clcr > or = to 55ml/min.
boolean
C0023508 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0373595 (UMLS CUI [7])
effective contraception
Item
effective contraception
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
exposure to osi-774
Item
prior exposure to osi-774 or other treatments targeting the her family axis (e.g.-trastuzumab, zd1839, c225, etc.)
boolean
C1135137 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
chemotherapy
Item
two or more prior chemotherapy regimens
boolean
C0392920 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
active cancer
Item
concurrent active cancer
boolean
C0006826 (UMLS CUI [1])
central nervous system metastases
Item
uncontrolled central nervous system metastases (i.e. any known cns lesion which is radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids)
boolean
C0686377 (UMLS CUI [1])
pregnancy or lactating
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
malignancies
Item
malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
boolean
C0006826 (UMLS CUI [1])
systemic cytotoxic chemotherapy
Item
prior systemic cytotoxic chemotherapy for other malignant disease
boolean
C0677881 (UMLS CUI [1])
comorbidity
Item
significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure, recent mi, unstable angina, active infection, uncontrolled hypertension).
boolean
C0009488 (UMLS CUI [1])
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