ID

16773

Beschreibung

Phase I Trial of huA33 Plus Chemotherapy in Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00199797

Link

https://clinicaltrials.gov/show/NCT00199797

Stichworte

Versionen (1)
  1. 05.08.16 05.08.16 -
Hochgeladen am

5. August 2016

DOI

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Eligibility Colorectal Cancer NCT00199797

Englisch

Eligibility Colorectal Cancer NCT00199797

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients will be eligible for enrollment if they fulfill all of the following criteria:
Beschreibung

criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. metastatic colorectal cancer
Beschreibung

Colorectal cancer metastatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0948380
2. histologically or cytologically proven colorectal cancer
Beschreibung

Colorectal Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0009402
3. expected survival of at least 4 months.
Beschreibung

Survival time Expected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2919552
UMLS CUI [1,2]
C1517001
4. not more than 2 different pretreatment regimens
Beschreibung

Pretreatment Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3539076
UMLS CUI [1,2]
C1265611
5. ecog performance status 0-2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. within the 2 weeks prior to the first dose of hua33, the following vital laboratory parameters:
Beschreibung

A33 monoclonal antibody

Datentyp

boolean

Alias
UMLS CUI [1]
C0392959
lab parameter range
Beschreibung

Laboratory Results

Datentyp

boolean

Alias
UMLS CUI [1]
C1254595
neutrophil count > 1.5 x 109/l
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 150 x 109/l
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
serum bilirubin < 2 mg/dl
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
creatinine clearance >50 ml/ min
Beschreibung

Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
7. age ≥ 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
8. able and willing to give valid written informed consent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded from the study for any of the following reasons:
Beschreibung

Exclusion Reasons

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0392360
1. untreated active metastatic disease to the central nervous system defined as new or enlarging lesions on ct or mri.
Beschreibung

CNS metastases | New Lesion X-Ray Computed Tomography | Lesion Enlarged X-Ray Computed Tomography | New Lesion Magnetic Resonance Imaging | Lesion Enlarged Magnetic Resonance Imaging

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C2986548
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0442800
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C2986548
UMLS CUI [4,2]
C0024485
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C0442800
UMLS CUI [5,3]
C0024485
2. surgery or radiotherapy of brain metastases within 3 months prior to the first dose of hua33.
Beschreibung

Operative Surgical Procedures Metastatic malignant neoplasm to brain | Therapeutic radiology procedure Metastatic malignant neoplasm to brain | A33 monoclonal antibody

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0220650
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0220650
UMLS CUI [3]
C0392959
3. metastatic disease involving > 50% of liver volume.
Beschreibung

Neoplasm Metastasis Involvement with Liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0023884
4. other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
Beschreibung

Illness Serious | Communicable Diseases Serious Requirement Antibiotics | Blood Coagulation Disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0003232
UMLS CUI [3]
C0005779
5. chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing (6 weeks for nitrosoureas).
Beschreibung

Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Nitrosoureas

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0028210
6. previous treatment with oxaliplatin.
Beschreibung

oxaliplatin

Datentyp

boolean

Alias
UMLS CUI [1]
C0069717
7. previous treatment with hua33 monoclonal antibody or antibody fragment.
Beschreibung

A33 monoclonal antibody | A33 monoclonal antibody Fragment

Datentyp

boolean

Alias
UMLS CUI [1]
C0392959
UMLS CUI [2,1]
C0392959
UMLS CUI [2,2]
C0332255
8. concomitant treatment with systemic corticosteroids. topical or inhalational corticosteroids are permitted.
Beschreibung

systemic steroids | Topical corticosteroids | inhaled steroids

Datentyp

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C0304604
UMLS CUI [3]
C2065041
9. known hiv, hepatitis b or c positivity.
Beschreibung

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
10. mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
Beschreibung

Mental impairment Informed Consent Limited | Mental impairment Protocol Compliance Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1112722
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C1112722
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
11. lack of availability of the patient for clinical and laboratory follow-up assessment.
Beschreibung

Follow-up Patient Availability Lack

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0470187
UMLS CUI [1,4]
C0332268
12. participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
13. pregnancy or breastfeeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
14. women of childbearing potential: refusal or inability to use effective means of contraception.
Beschreibung

Childbearing Potential Contraceptive methods Refused | Childbearing Potential Contraceptive methods Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1705116
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1299582
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Ähnliche Modelle

Eligibility Colorectal Cancer NCT00199797

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
criteria Fulfill
Item
patients will be eligible for enrollment if they fulfill all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Colorectal cancer metastatic
Item
1. metastatic colorectal cancer
boolean
C0948380 (UMLS CUI [1])
Colorectal Carcinoma
Item
2. histologically or cytologically proven colorectal cancer
boolean
C0009402 (UMLS CUI [1])
Survival time Expected
Item
3. expected survival of at least 4 months.
boolean
C2919552 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Pretreatment Quantity
Item
4. not more than 2 different pretreatment regimens
boolean
C3539076 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
5. ecog performance status 0-2.
boolean
C1520224 (UMLS CUI [1])
A33 monoclonal antibody
Item
6. within the 2 weeks prior to the first dose of hua33, the following vital laboratory parameters:
boolean
C0392959 (UMLS CUI [1])
Laboratory Results
Item
lab parameter range
boolean
C1254595 (UMLS CUI [1])
Absolute neutrophil count
Item
neutrophil count > 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 150 x 109/l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
serum bilirubin < 2 mg/dl
boolean
C1278039 (UMLS CUI [1])
Creatinine clearance measurement
Item
creatinine clearance >50 ml/ min
boolean
C0373595 (UMLS CUI [1])
Age
Item
7. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
8. able and willing to give valid written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Reasons
Item
patients will be excluded from the study for any of the following reasons:
boolean
C2828389 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
CNS metastases | New Lesion X-Ray Computed Tomography | Lesion Enlarged X-Ray Computed Tomography | New Lesion Magnetic Resonance Imaging | Lesion Enlarged Magnetic Resonance Imaging
Item
1. untreated active metastatic disease to the central nervous system defined as new or enlarging lesions on ct or mri.
boolean
C0686377 (UMLS CUI [1])
C2986548 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0442800 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C2986548 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0221198 (UMLS CUI [5,1])
C0442800 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
Operative Surgical Procedures Metastatic malignant neoplasm to brain | Therapeutic radiology procedure Metastatic malignant neoplasm to brain | A33 monoclonal antibody
Item
2. surgery or radiotherapy of brain metastases within 3 months prior to the first dose of hua33.
boolean
C0543467 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C0392959 (UMLS CUI [3])
Neoplasm Metastasis Involvement with Liver
Item
3. metastatic disease involving > 50% of liver volume.
boolean
C0027627 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
Illness Serious | Communicable Diseases Serious Requirement Antibiotics | Blood Coagulation Disorders
Item
4. other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0003232 (UMLS CUI [2,4])
C0005779 (UMLS CUI [3])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Nitrosoureas
Item
5. chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing (6 weeks for nitrosoureas).
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0028210 (UMLS CUI [4])
oxaliplatin
Item
6. previous treatment with oxaliplatin.
boolean
C0069717 (UMLS CUI [1])
A33 monoclonal antibody | A33 monoclonal antibody Fragment
Item
7. previous treatment with hua33 monoclonal antibody or antibody fragment.
boolean
C0392959 (UMLS CUI [1])
C0392959 (UMLS CUI [2,1])
C0332255 (UMLS CUI [2,2])
systemic steroids | Topical corticosteroids | inhaled steroids
Item
8. concomitant treatment with systemic corticosteroids. topical or inhalational corticosteroids are permitted.
boolean
C2825233 (UMLS CUI [1])
C0304604 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
9. known hiv, hepatitis b or c positivity.
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
Mental impairment Informed Consent Limited | Mental impairment Protocol Compliance Limited
Item
10. mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
boolean
C1112722 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C1112722 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Follow-up Patient Availability Lack
Item
11. lack of availability of the patient for clinical and laboratory follow-up assessment.
boolean
C3274571 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
Study Subject Participation Status | Investigational New Drugs
Item
12. participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
13. pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Refused | Childbearing Potential Contraceptive methods Unable
Item
14. women of childbearing potential: refusal or inability to use effective means of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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