ID

18322

Description

A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839; ODM derived from: https://clinicaltrials.gov/show/NCT00212108

Link

https://clinicaltrials.gov/show/NCT00212108

Keywords

Versions (2)
  1. 10/31/16 10/31/16 -
  2. 10/31/16 10/31/16 -
Uploaded on

October 31, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Nasopharyngeal Carcinoma NCT00212108

English

Eligibility Nasopharyngeal Carcinoma NCT00212108

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically proven npc.
Description

Nasopharyngeal carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2931822
2. any clinical stage npc as defined by the ajcc/uicc system.
Description

Nasopharyngeal carcinoma | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C2931822
UMLS CUI [2]
C3258246
3. no prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents.
Description

Therapeutic radiology procedure | Chemoradiotherapy | Immunotherapy | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0436307
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0013230
4. no prior nsaids or corticosteroids for at least 4 weeks.
Description

Anti-Inflammatory Agents, Non-Steroidal | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C0001617
5. ecog performance status ≤ 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate end organ function
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
7. life expectancy > 3 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
8. signed informed consent -
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy.
Description

celecoxib Take Unable | gefitinib Take Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0538927
UMLS CUI [1,2]
C1290952
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1122962
UMLS CUI [2,2]
C1290952
UMLS CUI [2,3]
C1299582
2. tumor not visible on fibre nasopharyngoscopy for biopsy.
Description

Neoplasm Visible | Nasopharyngoscopy | Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0205379
UMLS CUI [2]
C0189025
UMLS CUI [3]
C0005558
3. known peptic ulcer disease.
Description

Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0030920
4. evidence of clinically active interstitial lung disease.
Description

Interstitial Lung Disease Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C0332120
5. previous or concomitant malignancies with the exception of adequately treated carcinoma-in-situ of the cervix and basal or squamous cell carcinoma of the skin.
Description

Malignant Neoplasms | Carcinoma in situ of uterine cervix Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0851140
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C1522326
6. women who are pregnant or lactating. females with child-bearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.
Description

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
7. women of childbearing potential who are not practising adequate contraception.
Description

Childbearing Potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
8. concurrent medical problems that would significantly limit compliance with the study.
Description

Comorbidity Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
9. presence of any underlying medical conditions (eg. unstable or uncompensated respiratory, cardiac, renal or hepatic disease) that in the opinion of the investigator would make the patient unsuitable for study participation.
Description

Medical condition Resulting in Study Subject Participation Status Inappropriate | Respiration Disorder Unstable | Respiration Disorder Uncompensated | Heart Disease Unstable | Heart Disease Uncompensated | Kidney Disease Unstable | Kidney Disease Uncompensated | Liver disease Unstable | Liver disease Uncompensated

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1548788
UMLS CUI [2,1]
C0035204
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0035204
UMLS CUI [3,2]
C0205433
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0018799
UMLS CUI [5,2]
C0205433
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0443343
UMLS CUI [7,1]
C0022658
UMLS CUI [7,2]
C0205433
UMLS CUI [8,1]
C0023895
UMLS CUI [8,2]
C0443343
UMLS CUI [9,1]
C0023895
UMLS CUI [9,2]
C0205433
10. known hypersensitivity to celecoxib and gefitinib or any of the excipients of the products, known sulphonamide sensitivity and allergic reaction following the ingestion of nsaids.
Description

Hypersensitivity celecoxib | Hypersensitivity gefitinib | Hypersensitivity celecoxib Excipient | Hypersensitivity gefitinib Excipient | Allergy to sulfonamides | Allergic Reaction NSAIDS Ingestion

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0538927
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1122962
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0538927
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1122962
UMLS CUI [4,3]
C0015237
UMLS CUI [5]
C0038757
UMLS CUI [6,1]
C1527304
UMLS CUI [6,2]
C0003211
UMLS CUI [6,3]
C0232478
11. known hiv, hbv or hcv infection. -
Description

HIV Infections | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
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Similar models

Eligibility Nasopharyngeal Carcinoma NCT00212108

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Nasopharyngeal carcinoma
Item
1. histologically proven npc.
boolean
C2931822 (UMLS CUI [1])
Nasopharyngeal carcinoma | TNM clinical staging
Item
2. any clinical stage npc as defined by the ajcc/uicc system.
boolean
C2931822 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
Therapeutic radiology procedure | Chemoradiotherapy | Immunotherapy | Investigational New Drugs
Item
3. no prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents.
boolean
C1522449 (UMLS CUI [1])
C0436307 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Anti-Inflammatory Agents, Non-Steroidal | Adrenal Cortex Hormones
Item
4. no prior nsaids or corticosteroids for at least 4 weeks.
boolean
C0003211 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
ECOG performance status
Item
5. ecog performance status ≤ 2.
boolean
C1520224 (UMLS CUI [1])
organ function
Item
6. adequate end organ function
boolean
C0678852 (UMLS CUI [1])
Life Expectancy
Item
7. life expectancy > 3 months.
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
8. signed informed consent -
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
celecoxib Take Unable | gefitinib Take Unable
Item
1. inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy.
boolean
C0538927 (UMLS CUI [1,1])
C1290952 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1122962 (UMLS CUI [2,1])
C1290952 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Neoplasm Visible | Nasopharyngoscopy | Biopsy
Item
2. tumor not visible on fibre nasopharyngoscopy for biopsy.
boolean
C0027651 (UMLS CUI [1,1])
C0205379 (UMLS CUI [1,2])
C0189025 (UMLS CUI [2])
C0005558 (UMLS CUI [3])
Peptic Ulcer
Item
3. known peptic ulcer disease.
boolean
C0030920 (UMLS CUI [1])
Interstitial Lung Disease Evidence of
Item
4. evidence of clinically active interstitial lung disease.
boolean
C0206062 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Malignant Neoplasms | Carcinoma in situ of uterine cervix Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated
Item
5. previous or concomitant malignancies with the exception of adequately treated carcinoma-in-situ of the cervix and basal or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0553723 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative
Item
6. women who are pregnant or lactating. females with child-bearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods Lacking
Item
7. women of childbearing potential who are not practising adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Comorbidity Compliance behavior Limited
Item
8. concurrent medical problems that would significantly limit compliance with the study.
boolean
C0009488 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Medical condition Resulting in Study Subject Participation Status Inappropriate | Respiration Disorder Unstable | Respiration Disorder Uncompensated | Heart Disease Unstable | Heart Disease Uncompensated | Kidney Disease Unstable | Kidney Disease Uncompensated | Liver disease Unstable | Liver disease Uncompensated
Item
9. presence of any underlying medical conditions (eg. unstable or uncompensated respiratory, cardiac, renal or hepatic disease) that in the opinion of the investigator would make the patient unsuitable for study participation.
boolean
C3843040 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1548788 (UMLS CUI [1,4])
C0035204 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0035204 (UMLS CUI [3,1])
C0205433 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0018799 (UMLS CUI [5,1])
C0205433 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0022658 (UMLS CUI [7,1])
C0205433 (UMLS CUI [7,2])
C0023895 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0023895 (UMLS CUI [9,1])
C0205433 (UMLS CUI [9,2])
Hypersensitivity celecoxib | Hypersensitivity gefitinib | Hypersensitivity celecoxib Excipient | Hypersensitivity gefitinib Excipient | Allergy to sulfonamides | Allergic Reaction NSAIDS Ingestion
Item
10. known hypersensitivity to celecoxib and gefitinib or any of the excipients of the products, known sulphonamide sensitivity and allergic reaction following the ingestion of nsaids.
boolean
C0020517 (UMLS CUI [1,1])
C0538927 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1122962 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0538927 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C1122962 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0038757 (UMLS CUI [5])
C1527304 (UMLS CUI [6,1])
C0003211 (UMLS CUI [6,2])
C0232478 (UMLS CUI [6,3])
HIV Infections | Hepatitis B | Hepatitis C
Item
11. known hiv, hbv or hcv infection. -
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
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