ID

5039

Description

ODM derived from http://clinicaltrials.gov/show/NCT00889343

Link

http://clinicaltrials.gov/show/NCT00889343

Keywords

Versions (4)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/29/15 9/29/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

April 17, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00889343 Colorectal Neoplasms

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
ECOG Performance Status of 0 to 2
Description

ECOG Performance Status of 0 to 2

Data type

boolean

Alias
UMLS CUI 2011AA
C1520224
Life expectancy of at least 12 weeks.
Description

Life expectancy of at least 12 weeks.

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
Subjects with at least one uni-dimensional (RECIST) measurable lesion of metastatic colorectal carcinoma after first-line chemotherapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab and had a progression subsequently. Lesions must be measured by CT-scan or MRI.
Description

Subjects with at least one uni-dimensional (RECIST) measurable lesion of metastatic colorectal carcinoma after first-line chemotherapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab and had a progression subsequently. Lesions must be measured by CT-scan or MRI.

Data type

boolean

Alias
UMLS CUI 2011AA
C1709926
UMLS CUI 2011AA
C1513040
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0040405
MedDRA 14.1
10011603
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0948380
MedDRA 14.1
10052358
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0796324
UMLS CUI 2011AA
C0596581
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C0796392
SNOMED CT 2011_0131
409406007
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Description

Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0005953
SNOMED CT 2011_0131
14016003
LOINC Version 232
MTHU016536
UMLS CUI 2011AA
C0542341
SNOMED CT 2011_0131
246464006
UMLS CUI 2011AA
C0232741
SNOMED CT 2011_0131
79036002
UMLS CUI 2011AA
C0232804
SNOMED CT 2011_0131
11953005
Hemoglobin
Description

Hemoglobin > 9.0 g/dl

Data type

boolean

Alias
UMLS CUI 2011AA
C0518015
Absolute Neutrophil Count, ANC
Description

Absolute neutrophil count (ANC) >1,500/mm3

Data type

boolean

Alias
UMLS CUI 2011AA
C0948762
MedDRA 14.1
10052033
Platelet count 100,000 microliter Total bilirubin < 1.5 times the upper limit of normal
Description

Platelet count 100,000 microliter Total bilirubin < 1.5 times the upper limit of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C1519815
ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
Description

ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)

Data type

boolean

Alias
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0441932
SNOMED CT 2011_0131
258322007
Alkaline phosphatase < 4 x upper limit of normal
Description

Alkaline phosphatase < 4 x upper limit of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C0002059
SNOMED CT 2011_0131
57056007
LOINC Version 232
MTHU005195
UMLS CUI 2011AA
C1519815
PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
Description

PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]

Data type

boolean

Alias
UMLS CUI 2011AA
CL434069
UMLS CUI 2011AA
CL415281
UMLS CUI 2011AA
C0030605
SNOMED CT 2011_0131
42525009
MedDRA 14.1
10000630
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C0150457
SNOMED CT 2011_0131
182764009
MedDRA 14.1
10053468
UMLS CUI 2011AA
C1564394
UMLS CUI 2011AA
C0019134
SNOMED CT 2011_0131
372877000
LOINC Version 232
MTHU003766
Serum creatinine < 1.5 x upper limit of normal
Description

Serum creatinine < 1.5 x upper limit of normal

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
Signed and dated informed consent before the start of specific protocol procedures
Description

Signed and dated informed consent before the start of specific protocol procedures

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
History of cardiac disease: congestive heart failure >NYHA class 2. Active CAD (MI more than 6 mo prior to study entry is allowed). Cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
Description

History of cardiac disease: congestive heart failure >NYHA class 2. Active CAD (MI more than 6 mo prior to study entry is allowed). Cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0018799
SNOMED CT 2011_0131
56265001
MedDRA 14.1
10061024
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
UMLS CUI 2011AA
C0010068
SNOMED CT 2011_0131
53741008
MedDRA 14.1
10068617
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0003195
SNOMED CT 2011_0131
67507000
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
History of HIV infection or chronic hepatitis B or C
Description

History of HIV infection or chronic hepatitis B or C

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
UMLS CUI 2011AA
C0524909
SNOMED CT 2011_0131
61977001
MedDRA 14.1
10008910
ICD-10-CM Version 2010
B18.1
UMLS CUI 2011AA
C0524910
SNOMED CT 2011_0131
128302006
MedDRA 14.1
10008912
ICD-10-CM Version 2010
B18.2
Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
Description

Active clinically serious infections (> grade 2 NCI-CTC version 3.0)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1560948
CTCAE 1105E
MTHU114619
UMLS CUI 2011AA
C1560949
CTCAE 1105E
MTHU115603
UMLS CUI 2011AA
C1560950
CTCAE 1105E
MTHU116429
Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
Description

Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)

Data type

boolean

Alias
UMLS CUI 2011AA
C0036525
SNOMED CT 2011_0131
77879006
MedDRA 14.1
10027474
UMLS CUI 2011AA
C0006118
SNOMED CT 2011_0131
126952004
MedDRA 14.1
10061019
ICD-9-CM Version 2011
239.6
UMLS CUI 2011AA
C1334722
Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
Description

Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)

Data type

boolean

Alias
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C0003299
SNOMED CT 2011_0131
255632006
LOINC Version 232
MTHU006781
History of organ allograft
Description

History of organ allograft

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0178784
LOINC Version 232
MTHU020170
UMLS CUI 2011AA
C0522536
Bleeding tendency, Bleeding Disorders
Description

Patients with evidence or history of bleeding diathesis

Data type

boolean

Alias
UMLS CUI 2011AA
C0005779
Kidney dialysis
Description

Patients undergoing renal dialysis

Data type

boolean

Alias
UMLS CUI 2011AA
C0917873
SNOMED CT 2011_0131
265764009
MedDRA 14.1
10049051
Dihydropyrimidine Dehydrogenase Deficiency
Description

Known deficit in Dihydropyrimidine Deshydrogenase (DPD)

Data type

boolean

Alias
UMLS CUI 2011AA
C1959620
SNOMED CT 2011_0131
77365006
MedDRA 14.1
10052622
Contraindications for the use of atropine in patients receiving FOLFIRI
Description

Contraindications for the use of atropine in patients receiving FOLFIRI

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0004259
SNOMED CT 2011_0131
73949004
LOINC Version 232
MTHU002117
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1880658
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
Description

Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.

Data type

boolean

Alias
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C1527249
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C1336527
SNOMED CT 2011_0131
425231005
UMLS CUI 2011AA
C0475399
SNOMED CT 2011_0131
261663004
UMLS CUI 2011AA
C0475413
SNOMED CT 2011_0131
44401000
UMLS CUI 2011AA
C0475372
SNOMED CT 2011_0131
23351008
Peripheral sensory neuropathy > CTC grade 2
Description

Peripheral sensory neuropathy > CTC grade 2

Data type

boolean

Alias
UMLS CUI 2011AA
C0151313
SNOMED CT 2011_0131
95662005
MedDRA 14.1
10034620
CTCAE 1105E
E12768
UMLS CUI 2011AA
C1557260
CTCAE 1105E
MTHU114803
UMLS CUI 2011AA
C1557261
CTCAE 1105E
MTHU115776
UMLS CUI 2011AA
C1557262
CTCAE 1105E
MTHU116556
Chronic inflammatory bowel disease. Ileus. Genetic fructose intolerance
Description

Chronic inflammatory bowel disease. Ileus. Genetic fructose intolerance

Data type

boolean

Alias
UMLS CUI 2011AA
C1856359
UMLS CUI 2011AA
C1258215
SNOMED CT 2011_0131
81060008
MedDRA 14.1
10021328
CTCAE 1105E
E10812
UMLS CUI 2011AA
C0016751
SNOMED CT 2011_0131
20052008
MedDRA 14.1
10019878
ICD-10-CM Version 2010
E74.12
ICD-9-CM Version 2011
271.2
Pregnant or breast-feeding patients.
Description

Pregnant or breast-feeding patients.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
Women of childbearing potential must have a negative pregnancy test performed within 7 days before the start of treatment. Fertile women and men (<2 years after last menstruation in women) must use effective means of contraception (intrauterine contraceptive device, contraceptive implants, injectables (hormonal depot), transdermal hormonal contraception (contraceptive patch), sexual abstinence or vasectomised partner) during treatment and for at least 6 months after last administration of medication.
Description

Women of childbearing potential must have a negative pregnancy test performed within 7 days before the start of treatment. Fertile women and men (<2 years after last menstruation in women) must use effective means of contraception (intrauterine contraceptive device, contraceptive implants, injectables (hormonal depot), transdermal hormonal contraception (contraceptive patch), sexual abstinence or vasectomised partner) during treatment and for at least 6 months after last administration of medication.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
CL426012
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
CL424925
UMLS CUI 2011AA
C1262153
MedDRA 14.1
10062577
UMLS CUI 2011AA
C0419530
SNOMED CT 2011_0131
268464009
UMLS CUI 2011AA
C0694643
UMLS CUI 2011AA
CL424941
UMLS CUI 2011AA
CL424926
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Description

Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

Data type

boolean

Alias
UMLS CUI 2011AA
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C2348568
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0683954
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Description

Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C1113679
UMLS CUI 2011AA
C0231347
SNOMED CT 2011_0131
45704003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Patients unable to swallow oral medications.
Description

Patients unable to swallow oral medications.

Data type

boolean

Alias
UMLS CUI 2011AA
C0221470
SNOMED CT 2011_0131
249486008
MedDRA 14.1
10049866
ICD-10-CM Version 2010
R13.0
UMLS CUI 2011AA
C0304289
SNOMED CT 2011_0131
40461009
Any other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
Description

Any other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
CL426103
UMLS CUI 2011AA
C0392920
SNOMED CT 2011_0131
150415003
UMLS CUI 2011AA
C0021083
SNOMED CT 2011_0131
146638005
Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).
Description

Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).

Data type

boolean

Alias
UMLS CUI 2011AA
C0034619
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
UMLS CUI 2011AA
CL421682
major surgery
Description

Major surgery within 4 weeks of start of study

Data type

boolean

Alias
UMLS CUI 2011AA
C0679637
Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
Description

Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0194037
SNOMED CT 2011_0131
58776007
UMLS CUI 2011AA
C2825926
Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however, they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
Description

Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however, they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0005525
UMLS CUI 2011AA
C0079459
SNOMED CT 2011_0131
80572003
LOINC Version 232
MTHU031847
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Description

Investigational drug therapy outside of this trial during or within 4 weeks of study entry

Data type

boolean

Alias
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Prior exposure to the study drug.
Description

Prior exposure to the study drug.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Any St. John´s wort containing remedy
Description

Any St. John´s wort containing remedy

Data type

boolean

Alias
UMLS CUI 2011AA
C0936242
SNOMED CT 2011_0131
51621002
UMLS CUI 2011AA
C0332256
SNOMED CT 2011_0131
42504009
UMLS CUI 2011AA
C0013227
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
ECOG Performance Status of 0 to 2
Item
ECOG Performance Status of 0 to 2
boolean
C1520224 (UMLS CUI 2011AA)
Life expectancy of at least 12 weeks.
Item
Life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI 2011AA)
Subjects with at least one uni-dimensional (RECIST) measurable lesion of metastatic colorectal carcinoma after first-line chemotherapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab and had a progression subsequently. Lesions must be measured by CT-scan or MRI.
Item
Subjects with at least one uni-dimensional (RECIST) measurable lesion of metastatic colorectal carcinoma after first-line chemotherapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab and had a progression subsequently. Lesions must be measured by CT-scan or MRI.
boolean
C1709926 (UMLS CUI 2011AA)
C1513040 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0948380 (UMLS CUI 2011AA)
10052358 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0796324 (UMLS CUI 2011AA)
C0596581 (UMLS CUI 2011AA)
CL031856 (UMLS CUI 2011AA)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Item
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
Hemoglobin > 9.0 g/dl
Item
Hemoglobin
boolean
C0518015 (UMLS CUI 2011AA)
Absolute neutrophil count (ANC) >1,500/mm3
Item
Absolute Neutrophil Count, ANC
boolean
C0948762 (UMLS CUI 2011AA)
10052033 (MedDRA 14.1)
Platelet count 100,000 microliter Total bilirubin < 1.5 times the upper limit of normal
Item
Platelet count 100,000 microliter Total bilirubin < 1.5 times the upper limit of normal
boolean
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
Item
ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
boolean
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0441932 (UMLS CUI 2011AA)
258322007 (SNOMED CT 2011_0131)
Alkaline phosphatase < 4 x upper limit of normal
Item
Alkaline phosphatase < 4 x upper limit of normal
boolean
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
Item
PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
boolean
CL434069 (UMLS CUI 2011AA)
CL415281 (UMLS CUI 2011AA)
C0030605 (UMLS CUI 2011AA)
42525009 (SNOMED CT 2011_0131)
10000630 (MedDRA 14.1)
C1519815 (UMLS CUI 2011AA)
C0150457 (UMLS CUI 2011AA)
182764009 (SNOMED CT 2011_0131)
10053468 (MedDRA 14.1)
C1564394 (UMLS CUI 2011AA)
C0019134 (UMLS CUI 2011AA)
372877000 (SNOMED CT 2011_0131)
MTHU003766 (LOINC Version 232)
Serum creatinine < 1.5 x upper limit of normal
Item
Serum creatinine < 1.5 x upper limit of normal
boolean
C0201976 (UMLS CUI 2011AA)
Signed and dated informed consent before the start of specific protocol procedures
Item
Signed and dated informed consent before the start of specific protocol procedures
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
History of cardiac disease: congestive heart failure >NYHA class 2. Active CAD (MI more than 6 mo prior to study entry is allowed). Cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
Item
History of cardiac disease: congestive heart failure >NYHA class 2. Active CAD (MI more than 6 mo prior to study entry is allowed). Cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0003195 (UMLS CUI 2011AA)
67507000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
History of HIV infection or chronic hepatitis B or C
Item
History of HIV infection or chronic hepatitis B or C
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C0524909 (UMLS CUI 2011AA)
61977001 (SNOMED CT 2011_0131)
10008910 (MedDRA 14.1)
B18.1 (ICD-10-CM Version 2010)
C0524910 (UMLS CUI 2011AA)
128302006 (SNOMED CT 2011_0131)
10008912 (MedDRA 14.1)
B18.2 (ICD-10-CM Version 2010)
Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
Item
Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1560948 (UMLS CUI 2011AA)
MTHU114619 (CTCAE 1105E)
C1560949 (UMLS CUI 2011AA)
MTHU115603 (CTCAE 1105E)
C1560950 (UMLS CUI 2011AA)
MTHU116429 (CTCAE 1105E)
Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
Item
Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
boolean
C0036525 (UMLS CUI 2011AA)
77879006 (SNOMED CT 2011_0131)
10027474 (MedDRA 14.1)
C0006118 (UMLS CUI 2011AA)
126952004 (SNOMED CT 2011_0131)
10061019 (MedDRA 14.1)
239.6 (ICD-9-CM Version 2011)
C1334722 (UMLS CUI 2011AA)
Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
Item
Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
boolean
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0003299 (UMLS CUI 2011AA)
255632006 (SNOMED CT 2011_0131)
MTHU006781 (LOINC Version 232)
History of organ allograft
Item
History of organ allograft
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0178784 (UMLS CUI 2011AA)
MTHU020170 (LOINC Version 232)
C0522536 (UMLS CUI 2011AA)
Patients with evidence or history of bleeding diathesis
Item
Bleeding tendency, Bleeding Disorders
boolean
C0005779 (UMLS CUI 2011AA)
Patients undergoing renal dialysis
Item
Kidney dialysis
boolean
C0917873 (UMLS CUI 2011AA)
265764009 (SNOMED CT 2011_0131)
10049051 (MedDRA 14.1)
Known deficit in Dihydropyrimidine Deshydrogenase (DPD)
Item
Dihydropyrimidine Dehydrogenase Deficiency
boolean
C1959620 (UMLS CUI 2011AA)
77365006 (SNOMED CT 2011_0131)
10052622 (MedDRA 14.1)
Contraindications for the use of atropine in patients receiving FOLFIRI
Item
Contraindications for the use of atropine in patients receiving FOLFIRI
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0004259 (UMLS CUI 2011AA)
73949004 (SNOMED CT 2011_0131)
MTHU002117 (LOINC Version 232)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C1880658 (UMLS CUI 2011AA)
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
Item
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
CL411789 (UMLS CUI 2011AA)
C1527249 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
CL415147 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C1336527 (UMLS CUI 2011AA)
425231005 (SNOMED CT 2011_0131)
C0475399 (UMLS CUI 2011AA)
261663004 (SNOMED CT 2011_0131)
C0475413 (UMLS CUI 2011AA)
44401000 (SNOMED CT 2011_0131)
C0475372 (UMLS CUI 2011AA)
23351008 (SNOMED CT 2011_0131)
Peripheral sensory neuropathy > CTC grade 2
Item
Peripheral sensory neuropathy > CTC grade 2
boolean
C0151313 (UMLS CUI 2011AA)
95662005 (SNOMED CT 2011_0131)
10034620 (MedDRA 14.1)
E12768 (CTCAE 1105E)
C1557260 (UMLS CUI 2011AA)
MTHU114803 (CTCAE 1105E)
C1557261 (UMLS CUI 2011AA)
MTHU115776 (CTCAE 1105E)
C1557262 (UMLS CUI 2011AA)
MTHU116556 (CTCAE 1105E)
Chronic inflammatory bowel disease. Ileus. Genetic fructose intolerance
Item
Chronic inflammatory bowel disease. Ileus. Genetic fructose intolerance
boolean
C1856359 (UMLS CUI 2011AA)
C1258215 (UMLS CUI 2011AA)
81060008 (SNOMED CT 2011_0131)
10021328 (MedDRA 14.1)
E10812 (CTCAE 1105E)
C0016751 (UMLS CUI 2011AA)
20052008 (SNOMED CT 2011_0131)
10019878 (MedDRA 14.1)
E74.12 (ICD-10-CM Version 2010)
271.2 (ICD-9-CM Version 2011)
Pregnant or breast-feeding patients.
Item
Pregnant or breast-feeding patients.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
Women of childbearing potential must have a negative pregnancy test performed within 7 days before the start of treatment. Fertile women and men (<2 years after last menstruation in women) must use effective means of contraception (intrauterine contraceptive device, contraceptive implants, injectables (hormonal depot), transdermal hormonal contraception (contraceptive patch), sexual abstinence or vasectomised partner) during treatment and for at least 6 months after last administration of medication.
Item
Women of childbearing potential must have a negative pregnancy test performed within 7 days before the start of treatment. Fertile women and men (<2 years after last menstruation in women) must use effective means of contraception (intrauterine contraceptive device, contraceptive implants, injectables (hormonal depot), transdermal hormonal contraception (contraceptive patch), sexual abstinence or vasectomised partner) during treatment and for at least 6 months after last administration of medication.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
CL426012 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0419530 (UMLS CUI 2011AA)
268464009 (SNOMED CT 2011_0131)
C0694643 (UMLS CUI 2011AA)
CL424941 (UMLS CUI 2011AA)
CL424926 (UMLS CUI 2011AA)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Item
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
boolean
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
C0220825 (UMLS CUI 2011AA)
C0683954 (UMLS CUI 2011AA)
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Item
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C1113679 (UMLS CUI 2011AA)
C0231347 (UMLS CUI 2011AA)
45704003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patients unable to swallow oral medications.
Item
Patients unable to swallow oral medications.
boolean
C0221470 (UMLS CUI 2011AA)
249486008 (SNOMED CT 2011_0131)
10049866 (MedDRA 14.1)
R13.0 (ICD-10-CM Version 2010)
C0304289 (UMLS CUI 2011AA)
40461009 (SNOMED CT 2011_0131)
Any other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
Item
Any other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
CL426103 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0021083 (UMLS CUI 2011AA)
146638005 (SNOMED CT 2011_0131)
Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).
Item
Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed).
boolean
C0034619 (UMLS CUI 2011AA)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
CL421682 (UMLS CUI 2011AA)
Major surgery within 4 weeks of start of study
Item
major surgery
boolean
C0679637 (UMLS CUI 2011AA)
Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
Item
Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
boolean
C0194037 (UMLS CUI 2011AA)
58776007 (SNOMED CT 2011_0131)
C2825926 (UMLS CUI 2011AA)
Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however, they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
Item
Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however, they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0005525 (UMLS CUI 2011AA)
C0079459 (UMLS CUI 2011AA)
80572003 (SNOMED CT 2011_0131)
MTHU031847 (LOINC Version 232)
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Item
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
boolean
C0013230 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Prior exposure to the study drug.
Item
Prior exposure to the study drug.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Any St. John´s wort containing remedy
Item
Any St. John´s wort containing remedy
boolean
C0936242 (UMLS CUI 2011AA)
51621002 (SNOMED CT 2011_0131)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
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