ID

21848

Description

Phase I Study of Aprotinin in Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00354900

Link

https://clinicaltrials.gov/show/NCT00354900

Keywords

Versions (1)
  1. 5/4/17 5/4/17 -
Uploaded on

May 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00354900

English

Eligibility Metastatic Breast Cancer NCT00354900

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a histologically or cytologically proven metastatic breast cancer.
Description

Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0346993
patients with at least one bidimensionally measurable lesion (diameter > 1 cm), or an evaluable bone lesion that will not undergo biopsy.
Description

Measurable Disease 2-Dimensional Quantity | Measurable Disease Diameter | Bone lesion Evaluable | Biopsy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1301886
UMLS CUI [3,1]
C0238792
UMLS CUI [3,2]
C1516986
UMLS CUI [4,1]
C0005558
UMLS CUI [4,2]
C0332197
age > 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of at least 6 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status 0-3.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
screening laboratories within the following parameters: anc > 1500 cells/mm3, platelets > 100,000 cells/mm3, ast < 2 x upper limit of normal, bilirubin < 1.5 x upper limit of normal, calculated creatinine clearance > 30 cc/min by the cockroft and gault equation.
Description

Laboratory Results | Absolute neutrophil count | Platelet Count measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0201899
UMLS CUI [5]
C1278039
UMLS CUI [6]
C2711451
concurrent treatment with hormonal therapy or trastuzumab is allowed.
Description

Hormone Therapy | trastuzumab

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0728747
patients must be post-menopausal (either as a result of surgery, or amenorrhea for at least 12 consecutive months), or they must be practicing either abstinence, an adequate method of contraception (intrauterine device or barrier contraception), or their sexual partner must be sterile. women who are pregnant, breast-feeding, or who are fertile and not practicing an adequate means of contraception will be excluded.
Description

Postmenopausal Due to Operative Surgical Procedures | Amenorrhea Duration | Sexual Abstinence | Contraceptive methods | Intrauterine Devices | Contraception, Barrier | Sexual Partner Infertility | Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0036899
UMLS CUI [4]
C0700589
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0004764
UMLS CUI [7,1]
C0036911
UMLS CUI [7,2]
C0021359
UMLS CUI [8]
C0032961
UMLS CUI [9]
C0006147
UMLS CUI [10,1]
C3831118
UMLS CUI [10,2]
C0700589
UMLS CUI [10,3]
C0332268
patients must have a central venous catheter.
Description

Central venous catheter

Data type

boolean

Alias
UMLS CUI [1]
C1145640
patients must be able to give informed consent indicating that they are aware of the investigational nature of this study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no known cns metastases.
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
no treatment with cytotoxic chemotherapy allowed within 21 days of treatment with aprotinin.
Description

Cytotoxic Chemotherapy | Aprotinin

Data type

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C0003641
no treatment with investigational agents allowed within 21 days of treatment with aprotinin.
Description

Investigational New Drugs | Aprotinin

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0003641
no severe cardiovascular disease including unstable heart rhythm, uncompensated congestive heart failure, unstable angina or myocardial infarction within 6 months.
Description

Cardiovascular Disease Severe | Cardiac Arrhythmia | Congestive heart failure Uncompensated | Angina, Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0003811
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205433
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0027051
no bleeding diathesis or coagulopathy including concomitant use of anticoagulants for thromboembolic disease
Description

Bleeding tendency | Blood Coagulation Disorders | Anticoagulants Thromboembolism

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
UMLS CUI [3,1]
C0003280
UMLS CUI [3,2]
C0040038
no active anticoagulant therapy (including antiplatelet agents) for at least ten days.
Description

Anticoagulant therapy | Antiplatelet Agents

Data type

boolean

Alias
UMLS CUI [1]
C0150457
UMLS CUI [2]
C0085826
no active, uncontrolled bacterial, viral or fungal infection.
Description

Bacterial Infection Uncontrolled | Virus Disease Uncontrolled | Mycoses Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205318
no patients who are known or expected to be allergic to aprotinin, or who have received prior aprotinin.
Description

Aprotinin allergy | Aprotinin allergy Expected | Aprotinin Received

Data type

boolean

Alias
UMLS CUI [1]
C0571793
UMLS CUI [2,1]
C0571793
UMLS CUI [2,2]
C1517001
UMLS CUI [3,1]
C0003641
UMLS CUI [3,2]
C1514756
no patient with chronic systolic blood pressure (sbp) < 90 mm hg. if the (sbp) is < 90 mm hg on the day of treatment intravenous fluid may be administered to restore intravascular volume, if clinically indicated. in such case, if iv fluid corrects the sbp then the study drug may be given
Description

Systolic Pressure chronic | Administration of intravenous fluids | Volume Intravascular Restore | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0522792
UMLS CUI [3,1]
C0005850
UMLS CUI [3,2]
C0442123
UMLS CUI [3,3]
C1283255
UMLS CUI [4]
C0013230
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Similar models

Eligibility Metastatic Breast Cancer NCT00354900

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast
Item
patients with a histologically or cytologically proven metastatic breast cancer.
boolean
C0346993 (UMLS CUI [1])
Measurable Disease 2-Dimensional Quantity | Measurable Disease Diameter | Bone lesion Evaluable | Biopsy Absent
Item
patients with at least one bidimensionally measurable lesion (diameter > 1 cm), or an evaluable bone lesion that will not undergo biopsy.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0238792 (UMLS CUI [3,1])
C1516986 (UMLS CUI [3,2])
C0005558 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 6 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-3.
boolean
C1520224 (UMLS CUI [1])
Laboratory Results | Absolute neutrophil count | Platelet Count measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
screening laboratories within the following parameters: anc > 1500 cells/mm3, platelets > 100,000 cells/mm3, ast < 2 x upper limit of normal, bilirubin < 1.5 x upper limit of normal, calculated creatinine clearance > 30 cc/min by the cockroft and gault equation.
boolean
C1254595 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C2711451 (UMLS CUI [6])
Hormone Therapy | trastuzumab
Item
concurrent treatment with hormonal therapy or trastuzumab is allowed.
boolean
C0279025 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
Postmenopausal Due to Operative Surgical Procedures | Amenorrhea Duration | Sexual Abstinence | Contraceptive methods | Intrauterine Devices | Contraception, Barrier | Sexual Partner Infertility | Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
patients must be post-menopausal (either as a result of surgery, or amenorrhea for at least 12 consecutive months), or they must be practicing either abstinence, an adequate method of contraception (intrauterine device or barrier contraception), or their sexual partner must be sterile. women who are pregnant, breast-feeding, or who are fertile and not practicing an adequate means of contraception will be excluded.
boolean
C0232970 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0036899 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0036911 (UMLS CUI [7,1])
C0021359 (UMLS CUI [7,2])
C0032961 (UMLS CUI [8])
C0006147 (UMLS CUI [9])
C3831118 (UMLS CUI [10,1])
C0700589 (UMLS CUI [10,2])
C0332268 (UMLS CUI [10,3])
Central venous catheter
Item
patients must have a central venous catheter.
boolean
C1145640 (UMLS CUI [1])
Informed Consent
Item
patients must be able to give informed consent indicating that they are aware of the investigational nature of this study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS metastases
Item
no known cns metastases.
boolean
C0686377 (UMLS CUI [1])
Cytotoxic Chemotherapy | Aprotinin
Item
no treatment with cytotoxic chemotherapy allowed within 21 days of treatment with aprotinin.
boolean
C0677881 (UMLS CUI [1])
C0003641 (UMLS CUI [2])
Investigational New Drugs | Aprotinin
Item
no treatment with investigational agents allowed within 21 days of treatment with aprotinin.
boolean
C0013230 (UMLS CUI [1])
C0003641 (UMLS CUI [2])
Cardiovascular Disease Severe | Cardiac Arrhythmia | Congestive heart failure Uncompensated | Angina, Unstable | Myocardial Infarction
Item
no severe cardiovascular disease including unstable heart rhythm, uncompensated congestive heart failure, unstable angina or myocardial infarction within 6 months.
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C0205433 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
Bleeding tendency | Blood Coagulation Disorders | Anticoagulants Thromboembolism
Item
no bleeding diathesis or coagulopathy including concomitant use of anticoagulants for thromboembolic disease
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0003280 (UMLS CUI [3,1])
C0040038 (UMLS CUI [3,2])
Anticoagulant therapy | Antiplatelet Agents
Item
no active anticoagulant therapy (including antiplatelet agents) for at least ten days.
boolean
C0150457 (UMLS CUI [1])
C0085826 (UMLS CUI [2])
Bacterial Infection Uncontrolled | Virus Disease Uncontrolled | Mycoses Uncontrolled
Item
no active, uncontrolled bacterial, viral or fungal infection.
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0042769 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0026946 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Aprotinin allergy | Aprotinin allergy Expected | Aprotinin Received
Item
no patients who are known or expected to be allergic to aprotinin, or who have received prior aprotinin.
boolean
C0571793 (UMLS CUI [1])
C0571793 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
C0003641 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
Systolic Pressure chronic | Administration of intravenous fluids | Volume Intravascular Restore | Investigational New Drugs
Item
no patient with chronic systolic blood pressure (sbp) < 90 mm hg. if the (sbp) is < 90 mm hg on the day of treatment intravenous fluid may be administered to restore intravascular volume, if clinically indicated. in such case, if iv fluid corrects the sbp then the study drug may be given
boolean
C0871470 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0522792 (UMLS CUI [2])
C0005850 (UMLS CUI [3,1])
C0442123 (UMLS CUI [3,2])
C1283255 (UMLS CUI [3,3])
C0013230 (UMLS CUI [4])
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