Eligibility Lung Neoplasms NCT00090701

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StudyEvent: Eligibility
1. Eligibility Lung Neoplasms NCT00090701

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Non-small cell lung cancer metastatic Measurable

Item

presence of measurable, metastatic non-small cell lung cancer (histologically or cytologically confirmed at the time of original diagnosis)

boolean

C0278987 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])

Item

treatment failure (recurrence, disease progression, or intolerable toxicity) of 2 or 3 prior systemic treatments. (note: no more than 3 prior systemic regimens for non-small cell lung cancer including adjuvant chemotherapy)

boolean

C1515119 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0034897 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C0600688 (UMLS CUI [4])
C1515119 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0007131 (UMLS CUI [5,3])
C0085533 (UMLS CUI [6])

Informed Consent

Item

capable of understanding the nature of the trial and willing to give written informed consent

boolean

C0021430 (UMLS CUI [1])

ECOG performance status

Item

eastern cooperative oncology group (ecog) performance status of 0, 1 or 2

boolean

C1520224 (UMLS CUI [1])

Hemoglobin | Granulocyte count | Platelet Count measurement

Item

hemoglobin level of >=9 g/dl, absolute granulocyte count of >=1.5 × 109/l, and platelet count of >=100 × 109/l

boolean

C0019046 (UMLS CUI [1])
C0857490 (UMLS CUI [2])
C0032181 (UMLS CUI [3])

Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Item

adequate renal function, as documented by a serum creatinine level of <=1.5 times the institutional upper limit of normal (uln) and a measured or calculated creatinine clearance of >=60 ml/min

boolean

C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C2711451 (UMLS CUI [4])

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Liver Involvement

Item

adequate liver function, as demonstrated by a total bilirubin level of <=1.5 times uln; levels of serum glutamate oxaloacetic transaminase (sgot) (aspartate aminotransferase [ast]) and serum glutamate pyruvate transaminase (sgpt) (alanine aminotransferase [alt]) <=2 times uln. if the patient has liver involvement then ast and alt should be <=5 times uln

boolean

C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0023884 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])

Gender Partner Childbearing Potential Contraceptive methods | Childbearing Potential Contraceptive methods | Childbearing Potential Sexual Abstinence | Age

Item

for men with partners of child-bearing potential and all women of childbearing potential, willingness to use adequate contraception or practice abstinence during the course of the study at least 18 years of age

boolean

C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,4])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])

Life Expectancy

Item

life expectancy estimated at greater than 12 weeks

boolean

C0023671 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Blood Transfusion

Item

history of blood transfusion within the last 14 days

boolean

C0005841 (UMLS CUI [1])

Allopurinol Patient need for

Item

need of concurrent administration of allopurinol

boolean

C0002144 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])

Therapeutic radiology procedure | Chemotherapy | Nitrosourea | Mitomycin | Toxic effect Patient Recovered

Item

history of radiotherapy or chemotherapy within 4 weeks (nitrosourea or mitomycin c within 6 weeks) of the anticipated first day of dosing (patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy)

boolean

C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0600688 (UMLS CUI [5,1])
C0030705 (UMLS CUI [5,2])
C0521108 (UMLS CUI [5,3])

Condition Excludes Protocol Compliance | Addictive Behavior Excludes Protocol Compliance | Family problems Exclude Protocol Compliance

Item

any psychological or sociological condition, addictive disorder, or family problems that might preclude compliance with the protocol

boolean

C0348080 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0424960 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])

medical condition Unstable Interferes with Study Protocol | medical condition Severe Interferes with Study Protocol

Item

any unstable or severe intercurrent medical condition that in the opinion of the investigator might interfere with achievement of study objectives

boolean

C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])

Investigational New Drugs | adverse effects Patient Recovered

Item

receipt of an investigational agent within 28 days before the anticipated first day of dosing (patient must have recovered from all acute effects of previously administered investigational agents)

boolean

C0013230 (UMLS CUI [1])
C0001688 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0521108 (UMLS CUI [2,3])

Pregnancy | Breast Feeding

Item

pregnant or breast-feeding

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Glycinamide Ribonucleotide Formyltransferase Inhibitor

Item

previous treatment with garft inhibitors

boolean

C1512220 (UMLS CUI [1])

Therapeutic radiology procedure Bone Marrow Percentage

Item

history of radiation therapy to more than 40% of the marrow space

boolean

C1522449 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])

Item

history of a malignancy (other than non-small cell lung cancer) except those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years

boolean

C0006826 (UMLS CUI [1])
C0007131 (UMLS CUI [2])
C0699893 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0154084 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C0006826 (UMLS CUI [6,1])
C1273390 (UMLS CUI [6,2])

Metastatic malignant neoplasm to brain Requirement Therapeutic procedure | Disease Progression

Item

active brain metastases (requiring treatment or progressing)

boolean

C0220650 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])

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Eligibility Lung Neoplasms NCT00090701