ID

28144

Beskrivning

A Study of Irinotecan Plus Cetuximab With or Without Enzastaurin in Patients With Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00437268

Länk

https://clinicaltrials.gov/show/NCT00437268

Nyckelord

Versioner (1)
  1. 2017-12-21 2017-12-21 -
Rättsinnehavare

See clinicaltrials.gov

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21 december 2017

DOI

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Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00437268

Engelsk

Eligibility Colorectal Cancer NCT00437268

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients are eligible to be included in the study only if they meet all of the following criteria:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. histologic diagnosis of colorectal cancer.
Beskrivning

Colorectal Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0009402
2. performance status of 0, 1, or 2 on the ecog performance status schedule.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
3. have had documented disease progression according to response evaluation criteria in solid tumors (recist; therasse et al. 2000) within 3 months after receiving folfox plus bevacizumab as first-line therapy for locally advanced or metastatic disease, or within 6 months after receiving folfox with or without bevacizumab in the adjuvant setting.
Beskrivning

Disease Progression | FOLFOX | bevacizumab | First line treatment Advanced disease Locally | First line treatment Neoplasm Metastasis | Adjuvant Setting

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0392943
UMLS CUI [3]
C0796392
UMLS CUI [4,1]
C1708063
UMLS CUI [4,2]
C0679246
UMLS CUI [4,3]
C1517927
UMLS CUI [5,1]
C1708063
UMLS CUI [5,2]
C0027627
UMLS CUI [6]
C4084850
4. standard radiation therapy for rectal cancer is allowed. patients must have recovered from the toxic effects (except for alopecia) of the treatment prior to study enrollment. prior radiotherapy must be completed 4 weeks before study entry. lesions that have been radiated in the advanced setting cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
Beskrivning

Therapeutic radiology procedure Rectal Carcinoma | Toxic effect Except for Alopecia | Toxic effect Due to Prior Therapy | Patient recovered | Prior radiation therapy Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0007113
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0002170
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C1514463
UMLS CUI [4]
C1115804
UMLS CUI [5,1]
C0279134
UMLS CUI [5,2]
C0205197
5. at least one uni-dimensionally measurable lesion meeting recist guidelines (at least 10 mm in longest diameter by spiral computerized tomography [ct] scan, or at least 20 mm by standard techniques). positron emission tomography [pet] scans and ultrasounds may not be used.
Beskrivning

Measurable Disease Linear Quantity | Measurable Disease Longest Diameter Spiral CT scan | Measurable Disease Longest Diameter Standard Techniques | PET Absent | Ultrasonography Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0552406
UMLS CUI [2,3]
C0860888
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0552406
UMLS CUI [3,3]
C1442989
UMLS CUI [3,4]
C0449851
UMLS CUI [4,1]
C0032743
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0041618
UMLS CUI [5,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded from the study if they meet any of the following criteria:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry.
Beskrivning

Drugs, Non-Prescription

Datatyp

boolean

Alias
UMLS CUI [1]
C0013231
2. have previously completed or withdrawn from this study or any other study investigating enzastaurin, irinotecan, or cetuximab.
Beskrivning

Study Subject Participation Status Completion | Patient withdrawn from trial | enzastaurin | irinotecan | cetuximab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0422727
UMLS CUI [3]
C1327830
UMLS CUI [4]
C0123931
UMLS CUI [5]
C0995188
3. have a serious concomitant systemic disorder (eg, active infection including hiv, or cardiac disease) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
Beskrivning

Comorbidity Systemic Serious compromises Protocol Compliance | Communicable Disease | HIV Infection | Heart Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C2945640
UMLS CUI [1,5]
C0525058
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0018799
4. have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the new york heart association class iii or iv.
Beskrivning

Condition Cardiac Serious | Myocardial Infarction | Angina Pectoris | Heart Disease New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002962
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C1275491
5. have a prior malignancy (other than colorectal cancer, or adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer), unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. patients with a history of low grade (gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
Beskrivning

Cancer Other | Exception Colorectal Carcinoma | Exception Carcinoma in situ of uterine cervix Treated | Exception Skin carcinoma Treated | Exception Malignant Neoplasm Treated | Exception Recurrent Malignant Neoplasm Absent | Prostate carcinoma Localized Low grade Eligible | Gleason score

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0009402
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0006826
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1458156
UMLS CUI [6,3]
C0332197
UMLS CUI [7,1]
C0600139
UMLS CUI [7,2]
C0392752
UMLS CUI [7,3]
C1282907
UMLS CUI [7,4]
C1548635
UMLS CUI [8]
C3203027
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Similar models

Eligibility Colorectal Cancer NCT00437268

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients are eligible to be included in the study only if they meet all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Colorectal Carcinoma
Item
1. histologic diagnosis of colorectal cancer.
boolean
C0009402 (UMLS CUI [1])
ECOG performance status
Item
2. performance status of 0, 1, or 2 on the ecog performance status schedule.
boolean
C1520224 (UMLS CUI [1])
Disease Progression | FOLFOX | bevacizumab | First line treatment Advanced disease Locally | First line treatment Neoplasm Metastasis | Adjuvant Setting
Item
3. have had documented disease progression according to response evaluation criteria in solid tumors (recist; therasse et al. 2000) within 3 months after receiving folfox plus bevacizumab as first-line therapy for locally advanced or metastatic disease, or within 6 months after receiving folfox with or without bevacizumab in the adjuvant setting.
boolean
C0242656 (UMLS CUI [1])
C0392943 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
C1708063 (UMLS CUI [4,1])
C0679246 (UMLS CUI [4,2])
C1517927 (UMLS CUI [4,3])
C1708063 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
C4084850 (UMLS CUI [6])
Therapeutic radiology procedure Rectal Carcinoma | Toxic effect Except for Alopecia | Toxic effect Due to Prior Therapy | Patient recovered | Prior radiation therapy Completed
Item
4. standard radiation therapy for rectal cancer is allowed. patients must have recovered from the toxic effects (except for alopecia) of the treatment prior to study enrollment. prior radiotherapy must be completed 4 weeks before study entry. lesions that have been radiated in the advanced setting cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
boolean
C1522449 (UMLS CUI [1,1])
C0007113 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0002170 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C1514463 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4])
C0279134 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
Measurable Disease Linear Quantity | Measurable Disease Longest Diameter Spiral CT scan | Measurable Disease Longest Diameter Standard Techniques | PET Absent | Ultrasonography Absent
Item
5. at least one uni-dimensionally measurable lesion meeting recist guidelines (at least 10 mm in longest diameter by spiral computerized tomography [ct] scan, or at least 20 mm by standard techniques). positron emission tomography [pet] scans and ultrasounds may not be used.
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0552406 (UMLS CUI [2,2])
C0860888 (UMLS CUI [2,3])
C1513041 (UMLS CUI [3,1])
C0552406 (UMLS CUI [3,2])
C1442989 (UMLS CUI [3,3])
C0449851 (UMLS CUI [3,4])
C0032743 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0041618 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients will be excluded from the study if they meet any of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Drugs, Non-Prescription
Item
1. have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry.
boolean
C0013231 (UMLS CUI [1])
Study Subject Participation Status Completion | Patient withdrawn from trial | enzastaurin | irinotecan | cetuximab
Item
2. have previously completed or withdrawn from this study or any other study investigating enzastaurin, irinotecan, or cetuximab.
boolean
C2348568 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2])
C1327830 (UMLS CUI [3])
C0123931 (UMLS CUI [4])
C0995188 (UMLS CUI [5])
Comorbidity Systemic Serious compromises Protocol Compliance | Communicable Disease | HIV Infection | Heart Disease
Item
3. have a serious concomitant systemic disorder (eg, active infection including hiv, or cardiac disease) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
boolean
C0009488 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C2945640 (UMLS CUI [1,4])
C0525058 (UMLS CUI [1,5])
C0009450 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
Condition Cardiac Serious | Myocardial Infarction | Angina Pectoris | Heart Disease New York Heart Association Classification
Item
4. have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the new york heart association class iii or iv.
boolean
C0348080 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
Cancer Other | Exception Colorectal Carcinoma | Exception Carcinoma in situ of uterine cervix Treated | Exception Skin carcinoma Treated | Exception Malignant Neoplasm Treated | Exception Recurrent Malignant Neoplasm Absent | Prostate carcinoma Localized Low grade Eligible | Gleason score
Item
5. have a prior malignancy (other than colorectal cancer, or adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer), unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. patients with a history of low grade (gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0009402 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0006826 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1458156 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C0600139 (UMLS CUI [7,1])
C0392752 (UMLS CUI [7,2])
C1282907 (UMLS CUI [7,3])
C1548635 (UMLS CUI [7,4])
C3203027 (UMLS CUI [8])
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