ID

16756

Descrição

Evaluating Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00083616

Link

https://clinicaltrials.gov/show/NCT00083616

Palavras-chave

  1. 04/08/2016 04/08/2016 -
  2. 04/08/2016 04/08/2016 -
  3. 04/08/2016 04/08/2016 -
Transferido a

4 de agosto de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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Eligibility Colorectal Cancer NCT00083616

Eligibility Colorectal Cancer NCT00083616

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 (ecog) performance status 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 epidermal growth factor receptor (egfr) by immunohistochemistry
Descrição

Malignant Neoplasm | Epidermal Growth Factor Receptor Gene Expression | Immunohistochemistry

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0034802
UMLS CUI [2,2]
C0017262
UMLS CUI [3]
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 | Requirement Therapeutic procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0087111
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 epidermal growth factor receptor targeting agents
Descrição

Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0034802
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 with longer serum half-life (e.g., avastintm) within 6 weeks before enrollment
Descrição

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

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 [5,1]
C0033684
UMLS CUI [5,2]
C0599113
UMLS CUI [6]
C1135130

Similar models

Eligibility Colorectal Cancer NCT00083616

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 (ecog) performance status 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 Neoplasm | Epidermal Growth Factor Receptor Gene Expression | Immunohistochemistry
Item
tumor expressing epidermal growth factor receptor (egfr) by immunohistochemistry
boolean
C0006826 (UMLS CUI [1])
C0034802 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0021044 (UMLS CUI [3])
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 | Requirement Therapeutic procedure
Item
symptomatic brain metastases requiring treatment
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0087111 (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])
Pharmaceutical Preparations Targeting Epidermal Growth Factor Receptor
Item
prior epidermal growth factor receptor targeting agents
boolean
C0013227 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0034802 (UMLS CUI [1,3])
cancer treatment | Investigational New Drugs | Small Molecule Against Malignant Neoplasms | Biological Factors drug biological half life | Proteins drug biological half life | Avastin
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 with longer serum half-life (e.g., avastintm) 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])
C0033684 (UMLS CUI [5,1])
C0599113 (UMLS CUI [5,2])
C1135130 (UMLS CUI [6])

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