ID

38366

Description

Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3); ODM derived from: https://clinicaltrials.gov/show/NCT00599755

Link

https://clinicaltrials.gov/show/NCT00599755

Keywords

Versions (1)
  1. 10/13/19 10/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma NCT00599755

English

Eligibility Carcinoma NCT00599755

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00599755
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has histologically or cytopathologically confirmed metastatic or locally advanced stage iiib/iv non-small cell lung cancer (nsclc)
Description

Non-Small Cell Lung Carcinoma metastatic TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [2,4]
C3258246
has measurable disease
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
has not been previously treated with surgery (involving the thorax), radiation (unless it was for a metastatic site), or chemotherapy for nsclc
Description

Prior surgery Absent Non-Small Cell Lung Carcinoma | Involvement with Chest | Prior radiation therapy Absent Non-Small Cell Lung Carcinoma | Exception Prior radiation therapy Metastatic cancer site | Prior Chemotherapy Absent Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0007131
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0817096
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0007131
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0279134
UMLS CUI [4,3]
C0280457
UMLS CUI [5,1]
C1514457
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0007131
is 18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
has a performance status of 0-2 on the eastern cooperative oncology group (ecog) scale
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
women of childbearing potential have a negative pregnancy test
Description

Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
is participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the start of treatment
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
has untreated brain metastases related to their nsclc or carcinomatous meningitis
Description

Metastatic malignant neoplasm to brain Untreated | Relationship Non-Small Cell Lung Carcinoma | Relationship Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0007131
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0220654
abuses drugs or alcohol
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
is pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
is human immunodeficiency virus (hiv) positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
has active viral hepatitis
Description

Viral hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0042721
has hearing loss
Description

Hearing Loss

Data type

boolean

Alias
UMLS CUI [1]
C3887873
has poorly controlled diabetes mellitus
Description

Poorly controlled diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0554876
is allergic to gemcitabine, cisplatin or carboplatin
Description

Hypersensitivity Gemcitabine | Cisplatin allergy | Carboplatin allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0045093
UMLS CUI [2]
C0570702
UMLS CUI [3]
C0570701
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Similar models

Eligibility Carcinoma NCT00599755

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00599755
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma metastatic TNM clinical staging | Non-Small Cell Lung Carcinoma Advanced Locally TNM clinical staging
Item
has histologically or cytopathologically confirmed metastatic or locally advanced stage iiib/iv non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C3258246 (UMLS CUI [2,4])
Measurable Disease
Item
has measurable disease
boolean
C1513041 (UMLS CUI [1])
Prior surgery Absent Non-Small Cell Lung Carcinoma | Involvement with Chest | Prior radiation therapy Absent Non-Small Cell Lung Carcinoma | Exception Prior radiation therapy Metastatic cancer site | Prior Chemotherapy Absent Non-Small Cell Lung Carcinoma
Item
has not been previously treated with surgery (involving the thorax), radiation (unless it was for a metastatic site), or chemotherapy for nsclc
boolean
C0455610 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C0817096 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0007131 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0279134 (UMLS CUI [4,2])
C0280457 (UMLS CUI [4,3])
C1514457 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0007131 (UMLS CUI [5,3])
Age
Item
is 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
has a performance status of 0-2 on the eastern cooperative oncology group (ecog) scale
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
women of childbearing potential have a negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
is participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the start of treatment
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Metastatic malignant neoplasm to brain Untreated | Relationship Non-Small Cell Lung Carcinoma | Relationship Meningeal Carcinomatosis
Item
has untreated brain metastases related to their nsclc or carcinomatous meningitis
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0220654 (UMLS CUI [3,2])
Substance Use Disorders
Item
abuses drugs or alcohol
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
is pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
is human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Viral hepatitis
Item
has active viral hepatitis
boolean
C0042721 (UMLS CUI [1])
Hearing Loss
Item
has hearing loss
boolean
C3887873 (UMLS CUI [1])
Poorly controlled diabetes mellitus
Item
has poorly controlled diabetes mellitus
boolean
C0554876 (UMLS CUI [1])
Hypersensitivity Gemcitabine | Cisplatin allergy | Carboplatin allergy
Item
is allergic to gemcitabine, cisplatin or carboplatin
boolean
C0020517 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
C0570702 (UMLS CUI [2])
C0570701 (UMLS CUI [3])
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