ID

14829

Beskrivning

Safety, Efficacy and Pharmacokinetic Between Capecitabine and Exisulind in Metastatic Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00037609

Länk

https://clinicaltrials.gov/show/NCT00037609

Nyckelord

Versioner (1)
  1. 2016-05-01 2016-05-01 -
Uppladdad den

1 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00037609

Engelsk

Eligibility Breast Neoplasms NCT00037609

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
each patient must meet all these criteria in order to be considered for enrollment in the phase i study:
Beskrivning

ID.1

Datatyp

boolean

histologically confirmed breast cancer and either clinical, radiological or laboratory evidence of metastatic disease.
Beskrivning

ID.2

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0019638
UMLS CUI [2]
C0027627
patients must have received both anthracycline-containing and chemotherapy either as adjuvant treatment or therapy for metastatic breast cancer.
Beskrivning

ID.3

Datatyp

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2]
C3541958
there is no limit on prior chemotherapy regimens or hormonal therapies received.
Beskrivning

ID.4

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0449295
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0449295
concomitant bisphosphonate treatment is allowed for patients with bone metastases.
Beskrivning

ID.5

Datatyp

boolean

Alias
UMLS CUI [1]
C0153690
patients must have recovered from acute toxic effects of any prior therapy including surgery and radiation.
Beskrivning

ID.6

Datatyp

boolean

Alias
UMLS CUI [1]
C2004454
zubrod performance status < 2. (see appendix a)
Beskrivning

ID.7

Datatyp

boolean

Alias
UMLS CUI [1]
C1518965
adequate bone marrow function: platelets > 100,000/mm3, anc > 1500 cells/mm3, hemoglobin > 8g/dl.
Beskrivning

ID.8

Datatyp

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
normal renal function: creatinine < 2.0 mg/dl.
Beskrivning

ID.9

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
adequate liver function: bilirubin < 1.5 mg/dl. transaminases (sgot) or ldh, and alkaline phosphatase must be <1.5 x of the upper limit of normal in the absence of bone or liver metastasis, or <2.5 x of the upper limit of normal in the presence of radiologically apparent liver metastasis or bone metastasis, respectively.
Beskrivning

ID.10

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0002594
UMLS CUI [3]
C0202113
UMLS CUI [4]
C0201850
female patients must be of non-childbearing potential or non-lactating and using adequate contraception. beta-hcg will be checked in premenopausal patients if clinically indicated.
Beskrivning

ID.11

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with brain metastases whose disease remained for more than 6 months after completing therapy to the brain are eligible.
Beskrivning

ID.12

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0205360
written informed consent.
Beskrivning

ID.13

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
in addition to the above, patients participating in the phase ii portion of this study:
Beskrivning

ID.14

Datatyp

boolean

must have bidimensionally measurable or evaluable disease. lytic lesions seen on plain radiographs will be considered evaluable in conjunction with bone scan abnormalities. bone scan abnormalities alone, pure blastic bone metastases or irradiated lesions are not considered measurable or evaluable and will not be accepted. also, pleural or peritoneal effusions will not be considered evaluable disease.
Beskrivning

ID.15

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
a patient must not be enrolled if any of the following criteria applies:
Beskrivning

ID.16

Datatyp

boolean

known hypersensitivity to sulindac (clinoril).
Beskrivning

ID.17

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0038792
known hypersensitivity or contraindications to capecitabine (xelodar) including prior therapy with capecitabine.
Beskrivning

ID.18

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0671970
UMLS CUI [1,2]
C1301624
clinical or laboratory evidence of significant liver disease.
Beskrivning

ID.19

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
concomitant treatment with cytotoxic agents other than capecitabine or participation in any other investigational study.
Beskrivning

ID.20

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0304497
UMLS CUI [1,2]
C2347852
uncontrolled psychiatric, or social (addictive) disorders that would preclude obtaining informed consent or patient participation in the study.
Beskrivning

ID.21

Datatyp

boolean

Alias
UMLS CUI [1]
C0846574
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Similar models

Eligibility Breast Neoplasms NCT00037609

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
each patient must meet all these criteria in order to be considered for enrollment in the phase i study:
boolean
ID.2
Item
histologically confirmed breast cancer and either clinical, radiological or laboratory evidence of metastatic disease.
boolean
C0678222 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
ID.3
Item
patients must have received both anthracycline-containing and chemotherapy either as adjuvant treatment or therapy for metastatic breast cancer.
boolean
C0282564 (UMLS CUI [1])
C3541958 (UMLS CUI [2])
ID.4
Item
there is no limit on prior chemotherapy regimens or hormonal therapies received.
boolean
C0392920 (UMLS CUI [1,1])
C0449295 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0449295 (UMLS CUI [2,2])
ID.5
Item
concomitant bisphosphonate treatment is allowed for patients with bone metastases.
boolean
C0153690 (UMLS CUI [1])
ID.6
Item
patients must have recovered from acute toxic effects of any prior therapy including surgery and radiation.
boolean
C2004454 (UMLS CUI [1])
ID.7
Item
zubrod performance status < 2. (see appendix a)
boolean
C1518965 (UMLS CUI [1])
ID.8
Item
adequate bone marrow function: platelets > 100,000/mm3, anc > 1500 cells/mm3, hemoglobin > 8g/dl.
boolean
C0005821 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
ID.9
Item
normal renal function: creatinine < 2.0 mg/dl.
boolean
C0201976 (UMLS CUI [1])
ID.10
Item
adequate liver function: bilirubin < 1.5 mg/dl. transaminases (sgot) or ldh, and alkaline phosphatase must be <1.5 x of the upper limit of normal in the absence of bone or liver metastasis, or <2.5 x of the upper limit of normal in the presence of radiologically apparent liver metastasis or bone metastasis, respectively.
boolean
C1278039 (UMLS CUI [1])
C0002594 (UMLS CUI [2])
C0202113 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
ID.11
Item
female patients must be of non-childbearing potential or non-lactating and using adequate contraception. beta-hcg will be checked in premenopausal patients if clinically indicated.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
ID.12
Item
patients with brain metastases whose disease remained for more than 6 months after completing therapy to the brain are eligible.
boolean
C0220650 (UMLS CUI [1])
C0205360 (UMLS CUI [2])
ID.13
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
ID.14
Item
in addition to the above, patients participating in the phase ii portion of this study:
boolean
ID.15
Item
must have bidimensionally measurable or evaluable disease. lytic lesions seen on plain radiographs will be considered evaluable in conjunction with bone scan abnormalities. bone scan abnormalities alone, pure blastic bone metastases or irradiated lesions are not considered measurable or evaluable and will not be accepted. also, pleural or peritoneal effusions will not be considered evaluable disease.
boolean
C1513041 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.16
Item
a patient must not be enrolled if any of the following criteria applies:
boolean
ID.17
Item
known hypersensitivity to sulindac (clinoril).
boolean
C0020517 (UMLS CUI [1,1])
C0038792 (UMLS CUI [1,2])
ID.18
Item
known hypersensitivity or contraindications to capecitabine (xelodar) including prior therapy with capecitabine.
boolean
C0671970 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
ID.19
Item
clinical or laboratory evidence of significant liver disease.
boolean
C0023895 (UMLS CUI [1])
ID.20
Item
concomitant treatment with cytotoxic agents other than capecitabine or participation in any other investigational study.
boolean
C0304497 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
ID.21
Item
uncontrolled psychiatric, or social (addictive) disorders that would preclude obtaining informed consent or patient participation in the study.
boolean
C0846574 (UMLS CUI [1])
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