ID

20444

Beschrijving

Dose Escalating Study With BAY43-9006 With Carboplatin, Paclitaxel and Bevacizumab in Untreated Stage IIIb Non-small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT01069328

Link

https://clinicaltrials.gov/show/NCT01069328

Trefwoorden

Versies (1)
  1. 22-02-17 22-02-17 -
Geüploaded op

22 februari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01069328

Engels

Eligibility Carcinoma, Non-Small-Cell Lung NCT01069328

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have stage iiib (with malignant pleural effusions) or stage iv histological or cytological confirmation of non-small cell carcinoma (excluding squamous)
Beschrijving

Non-Small Cell Lung Carcinoma; Tumor stage; histological diagnosis; Cancer diagnosis based on cytological evidence | Pleural Effusion, Malignant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C1300072
UMLS CUI [2,1]
C0679557
UMLS CUI [2,2]
C1298647
UMLS CUI [3]
C0080032
age >/= 18 years old
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients must have at least 1 evaluable lesion. lesions must be evaluated by ct scan or mri
Beschrijving

Lesion Identification | X-Ray Computed Tomography | Magnetic Resonance Imaging

Datatype

boolean

Alias
UMLS CUI [1]
C2986383
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0024485
ecog performance status of 0 to 1
Beschrijving

ecog

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
Beschrijving

Renal function | Liver function | Organ or Tissue Function; Bone Marrow

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3,1]
C1254358
UMLS CUI [3,2]
C0005953
hemoglobin >/= 9.0 g/dl
Beschrijving

hemoglobin

Datatype

boolean

Alias
UMLS CUI [1]
C0019046
white blood cell (wbc) count >/= 2,500/mm3
Beschrijving

wbc

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count (anc) >/= 1,500/mm3
Beschrijving

anc

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelet count >/= 100,000/mm3
Beschrijving

platelet count

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin </= 1.5 times the upper limit of normal (uln)
Beschrijving

bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
alt and ast </= 2.5 x uln (</= 5 x uln for patients with liver involvement)
Beschrijving

alt, ast

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
inr </= 1.5 and aptt within normal limits
Beschrijving

inr

Datatype

boolean

Alias
UMLS CUI [1]
C0525032
serum creatinine </= uln or creatinine clearance (crcl) >/= 45 ml/min (crcl = wt (kg) x (140-age)/72 x cr level, female x 0.85) for patients with creatinine levels above institutional normal
Beschrijving

creatinine, creatinine clearance

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
urinalysis (ua) must show less than 1+ protein in urine, or the patient will require a repeat ua. if repeat ua shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein </= 1000 mg/24 hour to be eligible
Beschrijving

Urinalysis, protein, qualitative | Urine specimen collection, 24 hours; Urine total protein measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202512
UMLS CUI [2,1]
C0455060
UMLS CUI [2,2]
C0428541
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with squamous histology
Beschrijving

patients with squamous histology

Datatype

boolean

Alias
UMLS CUI [1]
C0149782
cardiac disease: congestive heart failure > class ii nyha; active coronary artery disease (mi more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Beschrijving

Heart Diseases | Congestive heart failure | Coronary Artery Disease | Ventricular arrhythmia; Anti-Arrhythmia Agent

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0018802
UMLS CUI [3]
C1956346
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C0003195
uncontrolled hypertension defined as systolic blood pressure > 150 mmhg or diastolic pressure > 90 mmhg despite optimal medical management
Beschrijving

uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
hiv infection or chronic hepatitis b or c
Beschrijving

hiv infection or chronic hepatitis b or c

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0524909
UMLS CUI [1,3]
C0524910
active clinically serious infections (> grade 2 nci-ctc version 3.0)
Beschrijving

active clinically serious infection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205177
evidence or history of cns disease, including primary brain tumors, seizures disorders, or any brain metastasis
Beschrijving

Medical History; CNS disorder; Primary malignant neoplasm of brain; Epilepsy; Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0007682
UMLS CUI [2]
C0750979
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0220650
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01069328

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma; Tumor stage; histological diagnosis; Cancer diagnosis based on cytological evidence | Pleural Effusion, Malignant
Item
patients must have stage iiib (with malignant pleural effusions) or stage iv histological or cytological confirmation of non-small cell carcinoma (excluding squamous)
boolean
C0007131 (UMLS CUI [1,1])
C1300072 (UMLS CUI [1,2])
C0679557 (UMLS CUI [2,1])
C1298647 (UMLS CUI [2,2])
C0080032 (UMLS CUI [3])
age
Item
age >/= 18 years old
boolean
C0001779 (UMLS CUI [1])
Lesion Identification | X-Ray Computed Tomography | Magnetic Resonance Imaging
Item
patients must have at least 1 evaluable lesion. lesions must be evaluated by ct scan or mri
boolean
C2986383 (UMLS CUI [1])
C0040405 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
ecog
Item
ecog performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Renal function | Liver function | Organ or Tissue Function; Bone Marrow
Item
adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C1254358 (UMLS CUI [3,1])
C0005953 (UMLS CUI [3,2])
hemoglobin
Item
hemoglobin >/= 9.0 g/dl
boolean
C0019046 (UMLS CUI [1])
wbc
Item
white blood cell (wbc) count >/= 2,500/mm3
boolean
C0023508 (UMLS CUI [1])
anc
Item
absolute neutrophil count (anc) >/= 1,500/mm3
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
platelet count >/= 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
bilirubin
Item
total bilirubin </= 1.5 times the upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
alt, ast
Item
alt and ast </= 2.5 x uln (</= 5 x uln for patients with liver involvement)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
inr
Item
inr </= 1.5 and aptt within normal limits
boolean
C0525032 (UMLS CUI [1])
creatinine, creatinine clearance
Item
serum creatinine </= uln or creatinine clearance (crcl) >/= 45 ml/min (crcl = wt (kg) x (140-age)/72 x cr level, female x 0.85) for patients with creatinine levels above institutional normal
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Urinalysis, protein, qualitative | Urine specimen collection, 24 hours; Urine total protein measurement
Item
urinalysis (ua) must show less than 1+ protein in urine, or the patient will require a repeat ua. if repeat ua shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein </= 1000 mg/24 hour to be eligible
boolean
C0202512 (UMLS CUI [1])
C0455060 (UMLS CUI [2,1])
C0428541 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
patients with squamous histology
Item
patients with squamous histology
boolean
C0149782 (UMLS CUI [1])
Heart Diseases | Congestive heart failure | Coronary Artery Disease | Ventricular arrhythmia; Anti-Arrhythmia Agent
Item
cardiac disease: congestive heart failure > class ii nyha; active coronary artery disease (mi more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
C0085612 (UMLS CUI [4,1])
C0003195 (UMLS CUI [4,2])
uncontrolled hypertension
Item
uncontrolled hypertension defined as systolic blood pressure > 150 mmhg or diastolic pressure > 90 mmhg despite optimal medical management
boolean
C1868885 (UMLS CUI [1])
hiv infection or chronic hepatitis b or c
Item
hiv infection or chronic hepatitis b or c
boolean
C0019693 (UMLS CUI [1,1])
C0524909 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
active clinically serious infection
Item
active clinically serious infections (> grade 2 nci-ctc version 3.0)
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
Medical History; CNS disorder; Primary malignant neoplasm of brain; Epilepsy; Metastatic malignant neoplasm to brain
Item
evidence or history of cns disease, including primary brain tumors, seizures disorders, or any brain metastasis
boolean
C0262926 (UMLS CUI [1,1])
C0007682 (UMLS CUI [1,2])
C0750979 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0220650 (UMLS CUI [4])
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