ID

18507

Description

Trial of Pemetrexed or Pemetrexed With Gemcitabine for Patients With Advanced Lung Cancer Who Are Not Eligible for Platinum-Based Chemotherapy and Have Not Previously Been Treated With Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00489983

Link

https://clinicaltrials.gov/show/NCT00489983

Keywords

Versions (2)
  1. 11/8/16 11/8/16 -
  2. 11/9/16 11/9/16 -
Uploaded on

November 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT00489983

English

Eligibility Non-Small Cell Lung Cancer NCT00489983

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed nsclc not amenable to surgery or radiotherapy of curative intent
Description

Non-Small Cell Lung Carcinoma Amenable Operative Surgical Procedure Curative intent | Non-Small Cell Lung Carcinoma Amenable Therapeutic radiology procedure Curative intent

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0543467
UMLS CUI [1,4]
C1276305
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C1522449
UMLS CUI [2,4]
C1276305
locally advanced or metastatic stage iiib (with n3 supraclavicular or t4 for pleural effusion) or iv nsclc
Description

Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | TNM clinical staging | Pleural effusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C0278987
UMLS CUI [3]
C3258246
UMLS CUI [4]
C0032227
no prior chemotherapy
Description

Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
measurable disease according to response evaluation criteria in solid tumors (recist) criteria (therasse et al. 2000)
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
men and women greater than or equal to 70 years of age or patients who, in the investigator’s opinion, are not eligible for platinum-based chemotherapy
Description

Age | Chemotherapy Platinum-Based Patient not eligible

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1514162
UMLS CUI [2,3]
C3242266
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Description

Non-Prescription Drugs Indication Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C1552551
have symptomatic brain metastases
Description

Metastatic malignant neoplasm to brain Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
have a history or presence of other malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
Description

Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated | Malignant Neoplasms Treated | Recurrence | melanoma | Breast Carcinoma | Renal Cell Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0851140
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C1522326
UMLS CUI [5]
C2825055
UMLS CUI [6]
C0025202
UMLS CUI [7]
C0678222
UMLS CUI [8]
C0007134
are unable to interrupt therapy with aspirin or other nonsteroidal anti-inflammatory drugs (nsaids) such as naproxen, piroxicam, diflunisal, or nabumetone around each dose of pemetrexed (5 days for short-acting or 8 days for long acting preparations)
Description

Therapeutic procedure Interrupt Unable | Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Naproxen | Piroxicam | Diflunisal | nabumetone | pemetrexed Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0443239
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0004057
UMLS CUI [3]
C0003211
UMLS CUI [4]
C0027396
UMLS CUI [5]
C0031990
UMLS CUI [6]
C0012228
UMLS CUI [7]
C0068334
UMLS CUI [8,1]
C0210657
UMLS CUI [8,2]
C0178602
are unable or unwilling to take steroids
Description

Steroids Intake Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0558080
are unable or unwilling to take folic acid or vitamin b12 supplementation
Description

Folate intake Unwilling | Vitamin B 12 supplementation Intake Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0564428
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0042845
UMLS CUI [2,2]
C0302837
UMLS CUI [2,3]
C1512806
UMLS CUI [2,4]
C0558080
have clinically detectable (by physical examination) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
Description

Ascites | Pleural effusion | Physical Examination | Drainage Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0031809
UMLS CUI [4,1]
C0013103
UMLS CUI [4,2]
C1272705
have other serious concomitant illness or medical conditions according to investigator criteria, including but not limited to the following:
Description

Comorbidity Investigator criteria | Medical condition Investigator criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0243161
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0008961
UMLS CUI [2,3]
C0243161
congestive heart failure or angina pectoris, except if it is medically controlled
Description

Congestive heart failure | Angina Pectoris | Congestive heart failure Controlled Medical | Angina Pectoris Controlled Medical

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002962
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C2911690
UMLS CUI [3,3]
C0205476
UMLS CUI [4,1]
C0002962
UMLS CUI [4,2]
C2911690
UMLS CUI [4,3]
C0205476
previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or arrhythmias
Description

Myocardial Infarction | Uncontrolled hypertension | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0003811
active infection requiring iv antibiotics
Description

Communicable Disease Requirement Intravenous antibiotic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0559680
active ulcer, unstable diabetes mellitus, or other contra-indication to corticotherapy
Description

Ulcer | Brittle diabetes | Medical contraindication Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0041582
UMLS CUI [2]
C0342302
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0001617
superior vena cava syndrome
Description

Superior Vena Cava Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0038833
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00489983

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Amenable Operative Surgical Procedure Curative intent | Non-Small Cell Lung Carcinoma Amenable Therapeutic radiology procedure Curative intent
Item
histologically or cytologically confirmed nsclc not amenable to surgery or radiotherapy of curative intent
boolean
C0007131 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C1276305 (UMLS CUI [1,4])
C0007131 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C1276305 (UMLS CUI [2,4])
Non-Small Cell Lung Carcinoma Advanced Locally | Non-small cell lung cancer metastatic | TNM clinical staging | Pleural effusion
Item
locally advanced or metastatic stage iiib (with n3 supraclavicular or t4 for pleural effusion) or iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C0278987 (UMLS CUI [2])
C3258246 (UMLS CUI [3])
C0032227 (UMLS CUI [4])
Prior Chemotherapy
Item
no prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
Measurable Disease
Item
measurable disease according to response evaluation criteria in solid tumors (recist) criteria (therasse et al. 2000)
boolean
C1513041 (UMLS CUI [1])
Age | Chemotherapy Platinum-Based Patient not eligible
Item
men and women greater than or equal to 70 years of age or patients who, in the investigator’s opinion, are not eligible for platinum-based chemotherapy
boolean
C0001779 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C3242266 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Non-Prescription Drugs Indication Any
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
boolean
C0013231 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Symptomatic
Item
have symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated | Malignant Neoplasms Treated | Recurrence | melanoma | Breast Carcinoma | Renal Cell Carcinoma
Item
have a history or presence of other malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C2825055 (UMLS CUI [5])
C0025202 (UMLS CUI [6])
C0678222 (UMLS CUI [7])
C0007134 (UMLS CUI [8])
Therapeutic procedure Interrupt Unable | Aspirin | Anti-Inflammatory Agents, Non-Steroidal | Naproxen | Piroxicam | Diflunisal | nabumetone | pemetrexed Dose
Item
are unable to interrupt therapy with aspirin or other nonsteroidal anti-inflammatory drugs (nsaids) such as naproxen, piroxicam, diflunisal, or nabumetone around each dose of pemetrexed (5 days for short-acting or 8 days for long acting preparations)
boolean
C0087111 (UMLS CUI [1,1])
C0443239 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0004057 (UMLS CUI [2])
C0003211 (UMLS CUI [3])
C0027396 (UMLS CUI [4])
C0031990 (UMLS CUI [5])
C0012228 (UMLS CUI [6])
C0068334 (UMLS CUI [7])
C0210657 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
Steroids Intake Unwilling
Item
are unable or unwilling to take steroids
boolean
C0038317 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Folate intake Unwilling | Vitamin B 12 supplementation Intake Unwilling
Item
are unable or unwilling to take folic acid or vitamin b12 supplementation
boolean
C0564428 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0042845 (UMLS CUI [2,1])
C0302837 (UMLS CUI [2,2])
C1512806 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
Ascites | Pleural effusion | Physical Examination | Drainage Unsuccessful
Item
have clinically detectable (by physical examination) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
boolean
C0003962 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0013103 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
Comorbidity Investigator criteria | Medical condition Investigator criteria
Item
have other serious concomitant illness or medical conditions according to investigator criteria, including but not limited to the following:
boolean
C0009488 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0008961 (UMLS CUI [2,2])
C0243161 (UMLS CUI [2,3])
Congestive heart failure | Angina Pectoris | Congestive heart failure Controlled Medical | Angina Pectoris Controlled Medical
Item
congestive heart failure or angina pectoris, except if it is medically controlled
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C2911690 (UMLS CUI [3,2])
C0205476 (UMLS CUI [3,3])
C0002962 (UMLS CUI [4,1])
C2911690 (UMLS CUI [4,2])
C0205476 (UMLS CUI [4,3])
Myocardial Infarction | Uncontrolled hypertension | Cardiac Arrhythmia
Item
previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or arrhythmias
boolean
C0027051 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
Communicable Disease Requirement Intravenous antibiotic therapy
Item
active infection requiring iv antibiotics
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0559680 (UMLS CUI [1,3])
Ulcer | Brittle diabetes | Medical contraindication Adrenal Cortex Hormones
Item
active ulcer, unstable diabetes mellitus, or other contra-indication to corticotherapy
boolean
C0041582 (UMLS CUI [1])
C0342302 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
Superior Vena Cava Syndrome
Item
superior vena cava syndrome
boolean
C0038833 (UMLS CUI [1])
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