ID

16764

Descrição

ABX-EGF (Panitumumab) Monotherapy in Subjects With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00089635

Link

https://clinicaltrials.gov/show/NCT00089635

Palavras-chave

Versões (2)
  1. 04/08/2016 04/08/2016 -
  2. 04/08/2016 04/08/2016 -
Transferido a

4 de agosto de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00089635

Inglês

Eligibility Colorectal Cancer NCT00089635

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
Descrição

Adenocarcinoma of large intestine | biopsy tissue

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1319315
UMLS CUI [2]
C3864006
metastatic colorectal carcinoma
Descrição

Colorectal cancer metastatic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948380
eastern cooperative oncology group of 0, 1 or 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
Descrição

Disease Progression Evidence of | Therapeutic procedure | fluoropyrimidine | irinotecan | oxaliplatin | Chemotherapy Colorectal cancer metastatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0596581
UMLS CUI [4]
C0123931
UMLS CUI [5]
C0069717
UMLS CUI [6,1]
C0392920
UMLS CUI [6,2]
C0948380
radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required
Descrição

Disease Progression | radiography | Chemotherapy Requirement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0034571
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1514873
bidimensionally measurable disease
Descrição

Measurable Disease 2-Dimensional

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
tumor expressing low to negative levels of egfr by immunohistochemistry
Descrição

Malignant Neoplasms | Gene Expression Epidermal Growth Factor Receptor Level low | Gene Expression Epidermal Growth Factor Receptor Level Negative | Immunohistochemistry

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0017262
UMLS CUI [2,2]
C0034802
UMLS CUI [2,3]
C0441889
UMLS CUI [2,4]
C0205251
UMLS CUI [3,1]
C0017262
UMLS CUI [3,2]
C0034802
UMLS CUI [3,3]
C0441889
UMLS CUI [3,4]
C0205160
UMLS CUI [4]
C0021044
at least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
Descrição

Prior Chemotherapy Quantity Colorectal cancer metastatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0948380
adequate hematologic, renal and hepatic function
Descrição

Hematologic function | Renal function | Liver function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
symptomatic brain metastases requiring treatment
Descrição

Metastatic malignant neoplasm to brain Symptomatic | Therapeutic procedure Requirement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1514873
patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis
Descrição

Interstitial Pneumonia History | Pulmonary Fibrosis History | Interstitial Pneumonia Evidence of | Pulmonary Fibrosis Evidence of

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0206061
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0034069
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0206061
UMLS CUI [3,2]
C0332120
UMLS CUI [4,1]
C0034069
UMLS CUI [4,2]
C0332120
use of systemic chemotherapy or radiotherapy within 30 days before enrollment
Descrição

Systemic Chemotherapy | Therapeutic radiology procedure Systemic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205373
prior anti-egfr antibody therapy with the exception of the small molecule egfr tyrosine kinase inhibitors, which are permitted
Descrição

Therapeutic procedure Against EGFR Antibody | Small Molecule Epidermal growth factor receptor inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C4055105
UMLS CUI [2,1]
C1328819
UMLS CUI [2,2]
C1443775
prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins within 6 weeks before enrollment
Descrição

cancer treatment | Investigational New Drugs | Small Molecule Against Malignant Neoplasms | Biological Factors drug biological half life Short | Proteins

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C1328819
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0006826
UMLS CUI [4,1]
C0005515
UMLS CUI [4,2]
C0599113
UMLS CUI [4,3]
C1806781
UMLS CUI [5]
C0033684
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Similar models

Eligibility Colorectal Cancer NCT00089635

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of large intestine | biopsy tissue
Item
pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by tissue biopsy)
boolean
C1319315 (UMLS CUI [1])
C3864006 (UMLS CUI [2])
Colorectal cancer metastatic
Item
metastatic colorectal carcinoma
boolean
C0948380 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Disease Progression Evidence of | Therapeutic procedure | fluoropyrimidine | irinotecan | oxaliplatin | Chemotherapy Colorectal cancer metastatic
Item
documented evidence of disease progression during, or following treatment, with fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal cancer
boolean
C0242656 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
C0596581 (UMLS CUI [3])
C0123931 (UMLS CUI [4])
C0069717 (UMLS CUI [5])
C0392920 (UMLS CUI [6,1])
C0948380 (UMLS CUI [6,2])
Disease Progression | radiography | Chemotherapy Requirement
Item
radiographic documentation of disease progression during or within 6 months following the most recent chemotherapy regimen is required
boolean
C0242656 (UMLS CUI [1])
C0034571 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Measurable Disease 2-Dimensional
Item
bidimensionally measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
Malignant Neoplasms | Gene Expression Epidermal Growth Factor Receptor Level low | Gene Expression Epidermal Growth Factor Receptor Level Negative | Immunohistochemistry
Item
tumor expressing low to negative levels of egfr by immunohistochemistry
boolean
C0006826 (UMLS CUI [1])
C0017262 (UMLS CUI [2,1])
C0034802 (UMLS CUI [2,2])
C0441889 (UMLS CUI [2,3])
C0205251 (UMLS CUI [2,4])
C0017262 (UMLS CUI [3,1])
C0034802 (UMLS CUI [3,2])
C0441889 (UMLS CUI [3,3])
C0205160 (UMLS CUI [3,4])
C0021044 (UMLS CUI [4])
Prior Chemotherapy Quantity Colorectal cancer metastatic
Item
at least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal cancer
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0948380 (UMLS CUI [1,3])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal and hepatic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain Symptomatic | Therapeutic procedure Requirement
Item
symptomatic brain metastases requiring treatment
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Interstitial Pneumonia History | Pulmonary Fibrosis History | Interstitial Pneumonia Evidence of | Pulmonary Fibrosis Evidence of
Item
patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis
boolean
C0206061 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0034069 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0206061 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C0034069 (UMLS CUI [4,1])
C0332120 (UMLS CUI [4,2])
Systemic Chemotherapy | Therapeutic radiology procedure Systemic
Item
use of systemic chemotherapy or radiotherapy within 30 days before enrollment
boolean
C1883256 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
Therapeutic procedure Against EGFR Antibody | Small Molecule Epidermal growth factor receptor inhibitor
Item
prior anti-egfr antibody therapy with the exception of the small molecule egfr tyrosine kinase inhibitors, which are permitted
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C4055105 (UMLS CUI [1,3])
C1328819 (UMLS CUI [2,1])
C1443775 (UMLS CUI [2,2])
cancer treatment | Investigational New Drugs | Small Molecule Against Malignant Neoplasms | Biological Factors drug biological half life Short | Proteins
Item
prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short (less than 1 week) serum half-life within 30 days before enrollment, or prior experimental or approved proteins within 6 weeks before enrollment
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C1328819 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0006826 (UMLS CUI [3,3])
C0005515 (UMLS CUI [4,1])
C0599113 (UMLS CUI [4,2])
C1806781 (UMLS CUI [4,3])
C0033684 (UMLS CUI [5])
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