ID

14531

Descrizione

Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00148070

collegamento

https://clinicaltrials.gov/show/NCT00148070

Keywords

  1. 19/04/16 19/04/16 -
Caricato su

19 aprile 2016

DOI

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Licenza

Creative Commons BY 4.0

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Eligibility Metastatic Breast Cancer NCT00148070

Eligibility Metastatic Breast Cancer NCT00148070

Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with biopsy proven, measurable metastatic breast cancer. patients with bone-only, and/or effusion-only disease are excluded.
Descrizione

Metastatic breast cancer

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2]
C0153690
UMLS CUI [3]
C0747641
karnofsky performance status equal to 70 or greater.
Descrizione

Karnofsky performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0206065
anc > 1500, hgb > 10, plt > 100.
Descrizione

ANC, hemoglobin and platelets

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0019046
UMLS CUI [3]
C0032181
patients with some degree of hepatic dysfunction and renal dysfunction are encouraged, in order to evaluate the ability of the ermbt in tailoring dose in these patient populations.
Descrizione

Liver and renal function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
age less than 18 years.
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
allergy to erythromycin.
Descrizione

Allergy to erythromycin

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014806
previous treatment with docetaxel. prior paclitaxel is allowed.
Descrizione

Docetaxel and paclitaxel

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0246415
UMLS CUI [2]
C0144576
grade > 2 peripheral neuropathy.
Descrizione

Peripheral neuropathy grade

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3869673
no confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy).
Descrizione

Confounding factors

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009673
patients who are pregnant or nursing will not be eligible for this protocol. women of childbearing age who are not practicing reliable birth control must have a documented negative serum hcg.
Descrizione

Gynaecological status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032976
patients who require concurrent treatment with drugs which are known to induce or inhibit cyp3a activity will be ineligible for the trial. this list includes the drugs midazolam, anti-mycotic agents (ketoconazole and related compounds), macrolide antibiotics (erythromycin and related compounds), nifedipine, anti-seizure drugs, and rifampin (induction).
Descrizione

Cyp3a inhibitors

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3850056

Similar models

Eligibility Metastatic Breast Cancer NCT00148070

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Metastatic breast cancer
Item
patients with biopsy proven, measurable metastatic breast cancer. patients with bone-only, and/or effusion-only disease are excluded.
boolean
C0278488 (UMLS CUI [1])
C0153690 (UMLS CUI [2])
C0747641 (UMLS CUI [3])
Karnofsky performance status
Item
karnofsky performance status equal to 70 or greater.
boolean
C0206065 (UMLS CUI [1])
ANC, hemoglobin and platelets
Item
anc > 1500, hgb > 10, plt > 100.
boolean
C0948762 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Liver and renal function
Item
patients with some degree of hepatic dysfunction and renal dysfunction are encouraged, in order to evaluate the ability of the ermbt in tailoring dose in these patient populations.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Age
Item
age less than 18 years.
boolean
C0001779 (UMLS CUI [1])
Allergy to erythromycin
Item
allergy to erythromycin.
boolean
C0020517 (UMLS CUI [1,1])
C0014806 (UMLS CUI [1,2])
Docetaxel and paclitaxel
Item
previous treatment with docetaxel. prior paclitaxel is allowed.
boolean
C0246415 (UMLS CUI [1])
C0144576 (UMLS CUI [2])
Peripheral neuropathy grade
Item
grade > 2 peripheral neuropathy.
boolean
C3869673 (UMLS CUI [1])
Confounding factors
Item
no confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy).
boolean
C0009673 (UMLS CUI [1])
Gynaecological status
Item
patients who are pregnant or nursing will not be eligible for this protocol. women of childbearing age who are not practicing reliable birth control must have a documented negative serum hcg.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
Cyp3a inhibitors
Item
patients who require concurrent treatment with drugs which are known to induce or inhibit cyp3a activity will be ineligible for the trial. this list includes the drugs midazolam, anti-mycotic agents (ketoconazole and related compounds), macrolide antibiotics (erythromycin and related compounds), nifedipine, anti-seizure drugs, and rifampin (induction).
boolean
C3850056 (UMLS CUI [1])

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