0 Ratings
ID

18452

Description

Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00073723

Link

https://clinicaltrials.gov/show/NCT00073723

Keywords

Versions (1)
  1. 11/6/16 11/6/16 -
Uploaded on

November 6, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Non-Small Cell Lung Cancer NCT00073723

    English

    Eligibility Non-Small Cell Lung Cancer NCT00073723

    1 forms  
    Criteria
    Description

    Criteria

    histologically or cytologically confirmed advanced stage iv nsclc with evidence of inoperable local recurrence or metastasis
    Description

    Non-Small Cell Lung Carcinoma Advanced | TNM clinical staging | Neoplasm Metastasis Recurrence Local Inoperable Evidence of

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007131
    UMLS CUI [1,2]
    C0205179
    UMLS CUI [2]
    C3258246
    UMLS CUI [3,1]
    C0027627
    UMLS CUI [3,2]
    C2825055
    UMLS CUI [3,3]
    C0205276
    UMLS CUI [3,4]
    C0205187
    UMLS CUI [3,5]
    C0332120
    if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
    Description

    Pregnancy | Breast Feeding | Serum pregnancy test negative | Childbearing Potential | Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3]
    C0430061
    UMLS CUI [4]
    C3831118
    UMLS CUI [5]
    C0700589
    eighteen years of age or older
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    no other current active malignancy
    Description

    Malignant Neoplasms

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    measurable disease (defined by recist criteria) documented radiographically
    Description

    Measurable Disease | Radiography

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    UMLS CUI [2]
    C0034571
    patient must have received no prior chemotherapies for the treatment of metastatic disease. radiation therapy to a major bone marrow-containing area must have been completed 3 or more weeks prior to study entry. prior treatment with egf-targeted therapies is permitted.
    Description

    Prior Chemotherapy Neoplasm Metastasis | Therapeutic radiology procedure Completed Bone Marrow Area Major | Epidermal Growth Factor Targeted Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0027627
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C0205197
    UMLS CUI [2,3]
    C0005953
    UMLS CUI [2,4]
    C0205146
    UMLS CUI [2,5]
    C0205164
    UMLS CUI [3,1]
    C0242275
    UMLS CUI [3,2]
    C2985566
    if, at baseline, patient has anc greater than or equal to 1.5 x 109 cells/l; platelets greater than or equal to 100 x 109 cells/l and hgb greater than or equal to 9 g/dl
    Description

    Absolute neutrophil count | Platelet Count measurement | Hemoglobin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    UMLS CUI [2]
    C0032181
    UMLS CUI [3]
    C0019046
    if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin normal; creatinine levels less than or equal to 1.5 mg/dl and alkaline phosphatase levels less than or equal to 2.5 x the upper limit of normal range (unless alkaline phosphatase elevation is felt to be related to bone metastases and there is no radiologic evidence of hepatic metastasis)
    Description

    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin total normal | Creatinine measurement, serum | Alkaline phosphatase measurement | Alkaline phosphatase raised Related Secondary malignant neoplasm of bone | Secondary malignant neoplasm of liver Evidence Radiologic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C0860928
    UMLS CUI [4]
    C0201976
    UMLS CUI [5]
    C0201850
    UMLS CUI [6,1]
    C0151849
    UMLS CUI [6,2]
    C0439849
    UMLS CUI [6,3]
    C0153690
    UMLS CUI [7,1]
    C0494165
    UMLS CUI [7,2]
    C3887511
    UMLS CUI [7,3]
    C0205483
    expected survival of greater than 12 weeks
    Description

    Continuance of life Expected

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0038952
    UMLS CUI [1,2]
    C1517001
    ecog performance status 0-1 (karnofsky > 70)
    Description

    ECOG performance status | Karnofsky Performance Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    UMLS CUI [2]
    C0206065
    patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.
    Description

    Informed Consent | Informed Consent Patient Representative | Informed Consent Legal Guardian

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0030701
    UMLS CUI [3,1]
    C0021430
    UMLS CUI [3,2]
    C0023226
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    Similar models

    Eligibility Non-Small Cell Lung Cancer NCT00073723

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Non-Small Cell Lung Carcinoma Advanced | TNM clinical staging | Neoplasm Metastasis Recurrence Local Inoperable Evidence of
    Item
    histologically or cytologically confirmed advanced stage iv nsclc with evidence of inoperable local recurrence or metastasis
    boolean
    C0007131 (UMLS CUI [1,1])
    C0205179 (UMLS CUI [1,2])
    C3258246 (UMLS CUI [2])
    C0027627 (UMLS CUI [3,1])
    C2825055 (UMLS CUI [3,2])
    C0205276 (UMLS CUI [3,3])
    C0205187 (UMLS CUI [3,4])
    C0332120 (UMLS CUI [3,5])
    Pregnancy | Breast Feeding | Serum pregnancy test negative | Childbearing Potential | Contraceptive methods
    Item
    if female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0430061 (UMLS CUI [3])
    C3831118 (UMLS CUI [4])
    C0700589 (UMLS CUI [5])
    Age
    Item
    eighteen years of age or older
    boolean
    C0001779 (UMLS CUI [1])
    Malignant Neoplasms
    Item
    no other current active malignancy
    boolean
    C0006826 (UMLS CUI [1])
    Measurable Disease | Radiography
    Item
    measurable disease (defined by recist criteria) documented radiographically
    boolean
    C1513041 (UMLS CUI [1])
    C0034571 (UMLS CUI [2])
    Prior Chemotherapy Neoplasm Metastasis | Therapeutic radiology procedure Completed Bone Marrow Area Major | Epidermal Growth Factor Targeted Therapy
    Item
    patient must have received no prior chemotherapies for the treatment of metastatic disease. radiation therapy to a major bone marrow-containing area must have been completed 3 or more weeks prior to study entry. prior treatment with egf-targeted therapies is permitted.
    boolean
    C1514457 (UMLS CUI [1,1])
    C0027627 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2,1])
    C0205197 (UMLS CUI [2,2])
    C0005953 (UMLS CUI [2,3])
    C0205146 (UMLS CUI [2,4])
    C0205164 (UMLS CUI [2,5])
    C0242275 (UMLS CUI [3,1])
    C2985566 (UMLS CUI [3,2])
    Absolute neutrophil count | Platelet Count measurement | Hemoglobin
    Item
    if, at baseline, patient has anc greater than or equal to 1.5 x 109 cells/l; platelets greater than or equal to 100 x 109 cells/l and hgb greater than or equal to 9 g/dl
    boolean
    C0948762 (UMLS CUI [1])
    C0032181 (UMLS CUI [2])
    C0019046 (UMLS CUI [3])
    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin total normal | Creatinine measurement, serum | Alkaline phosphatase measurement | Alkaline phosphatase raised Related Secondary malignant neoplasm of bone | Secondary malignant neoplasm of liver Evidence Radiologic
    Item
    if, at baseline, patient has ast and alt of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin normal; creatinine levels less than or equal to 1.5 mg/dl and alkaline phosphatase levels less than or equal to 2.5 x the upper limit of normal range (unless alkaline phosphatase elevation is felt to be related to bone metastases and there is no radiologic evidence of hepatic metastasis)
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0860928 (UMLS CUI [3])
    C0201976 (UMLS CUI [4])
    C0201850 (UMLS CUI [5])
    C0151849 (UMLS CUI [6,1])
    C0439849 (UMLS CUI [6,2])
    C0153690 (UMLS CUI [6,3])
    C0494165 (UMLS CUI [7,1])
    C3887511 (UMLS CUI [7,2])
    C0205483 (UMLS CUI [7,3])
    Continuance of life Expected
    Item
    expected survival of greater than 12 weeks
    boolean
    C0038952 (UMLS CUI [1,1])
    C1517001 (UMLS CUI [1,2])
    ECOG performance status | Karnofsky Performance Status
    Item
    ecog performance status 0-1 (karnofsky > 70)
    boolean
    C1520224 (UMLS CUI [1])
    C0206065 (UMLS CUI [2])
    Informed Consent | Informed Consent Patient Representative | Informed Consent Legal Guardian
    Item
    patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the informed consent form prior to participation in any study-related activities.
    boolean
    C0021430 (UMLS CUI [1])
    C0021430 (UMLS CUI [2,1])
    C0030701 (UMLS CUI [2,2])
    C0021430 (UMLS CUI [3,1])
    C0023226 (UMLS CUI [3,2])
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