ID

21873

Description

ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00415779

Link

https://clinicaltrials.gov/show/NCT00415779

Keywords

Versions (1)
  1. 5/5/17 5/5/17 -
Uploaded on

May 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Prostate Cancer NCT00415779

English

Eligibility Metastatic Prostate Cancer NCT00415779

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
hormone refractory prostate cancer
Description

Hormone refractory prostate cancer

Data type

boolean

Alias
UMLS CUI [1]
C1328504
stage iv disease with bone metastasis
Description

Disease TNM clinical staging | Secondary malignant neoplasm of bone

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0153690
no immunotherapy, hormonal therapy or radiotherapy within the previous month
Description

Immunotherapy Absent | Hormone Therapy Absent | Therapeutic radiology procedure Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
performance status < or = 2 (ecog)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
serum creatinine < 1.5 mg/100ml
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
serum bilirubin < or = 1.25 x unl (upper normal limit) (or < or = 1.5 x unl in the presence of hepatic metastases); sgot e sgpt < or = 1.5 x unl (or < or = 2.5 x unl in presence of hepatic metastases)
Description

Serum total bilirubin measurement | Secondary malignant neoplasm of liver | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0494165
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
left ventricular ejection fraction > or = 50% (measured by cardiac ultrasound or muga scan)
Description

Left ventricular ejection fraction Cardiac ultrasound | Left ventricular ejection fraction Multiple gated acquisition scanning

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C1655737
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
neutrophils > 1500/mm3; platelets >100000/mm3; hemoglobin >10 g/100 ml· life expectancy of at least 3 months
Description

Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous malignancies with the exception of radically treated epithelioma
Description

Malignant Neoplasms | Epithelioma Treated Radical

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0553707
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0439807
previous chemotherapy
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
comorbidities that would, in the investigator's opinion, contraindicate the use of the drugs in the study
Description

Comorbidity | Medical contraindication Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0013230
uncontrolled diabetes
Description

Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1]
C0421258
severe cardiac arrhythmias, severe uncontrolled congestive heart failure, severe ischemic cardiac disease or myocardial infarction within the previous 6 months
Description

Cardiac Arrhythmia Severe | Congestive heart failure Uncontrolled Severe | Myocardial Ischemia Severe | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0151744
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0027051
severe infection
Description

Communicable Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
cerebral metastasis
Description

Cerebral metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0555278
pre-existing motor or sensory neurotoxicity > or = grade 2 according to ctc (common toxicity criteria).
Description

Neurotoxicity Motor Pre-existing CTCAE Grades | Neurotoxicity Sensory Pre-existing CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0235032
UMLS CUI [1,2]
C0501384
UMLS CUI [1,3]
C2347662
UMLS CUI [1,4]
C1516728
UMLS CUI [2,1]
C0235032
UMLS CUI [2,2]
C0501385
UMLS CUI [2,3]
C2347662
UMLS CUI [2,4]
C1516728
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Similar models

Eligibility Metastatic Prostate Cancer NCT00415779

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Hormone refractory prostate cancer
Item
hormone refractory prostate cancer
boolean
C1328504 (UMLS CUI [1])
Disease TNM clinical staging | Secondary malignant neoplasm of bone
Item
stage iv disease with bone metastasis
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2])
Immunotherapy Absent | Hormone Therapy Absent | Therapeutic radiology procedure Absent
Item
no immunotherapy, hormonal therapy or radiotherapy within the previous month
boolean
C0021083 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
ECOG performance status
Item
performance status < or = 2 (ecog)
boolean
C1520224 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine < 1.5 mg/100ml
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Secondary malignant neoplasm of liver | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
serum bilirubin < or = 1.25 x unl (upper normal limit) (or < or = 1.5 x unl in the presence of hepatic metastases); sgot e sgpt < or = 1.5 x unl (or < or = 2.5 x unl in presence of hepatic metastases)
boolean
C1278039 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Left ventricular ejection fraction Cardiac ultrasound | Left ventricular ejection fraction Multiple gated acquisition scanning
Item
left ventricular ejection fraction > or = 50% (measured by cardiac ultrasound or muga scan)
boolean
C0428772 (UMLS CUI [1,1])
C1655737 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Life Expectancy
Item
neutrophils > 1500/mm3; platelets >100000/mm3; hemoglobin >10 g/100 ml· life expectancy of at least 3 months
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0023671 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Epithelioma Treated Radical
Item
previous malignancies with the exception of radically treated epithelioma
boolean
C0006826 (UMLS CUI [1])
C0553707 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0439807 (UMLS CUI [2,3])
Chemotherapy
Item
previous chemotherapy
boolean
C0392920 (UMLS CUI [1])
Comorbidity | Medical contraindication Investigational New Drugs
Item
comorbidities that would, in the investigator's opinion, contraindicate the use of the drugs in the study
boolean
C0009488 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Diabetic - poor control
Item
uncontrolled diabetes
boolean
C0421258 (UMLS CUI [1])
Cardiac Arrhythmia Severe | Congestive heart failure Uncontrolled Severe | Myocardial Ischemia Severe | Myocardial Infarction
Item
severe cardiac arrhythmias, severe uncontrolled congestive heart failure, severe ischemic cardiac disease or myocardial infarction within the previous 6 months
boolean
C0003811 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0151744 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
Communicable Disease Severe
Item
severe infection
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Cerebral metastasis
Item
cerebral metastasis
boolean
C0555278 (UMLS CUI [1])
Neurotoxicity Motor Pre-existing CTCAE Grades | Neurotoxicity Sensory Pre-existing CTCAE Grades
Item
pre-existing motor or sensory neurotoxicity > or = grade 2 according to ctc (common toxicity criteria).
boolean
C0235032 (UMLS CUI [1,1])
C0501384 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C0235032 (UMLS CUI [2,1])
C0501385 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
C1516728 (UMLS CUI [2,4])
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