ID

24993

Description

A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00480090

Link

https://clinicaltrials.gov/show/NCT00480090

Keywords

Versions (1)
  1. 8/23/17 8/23/17 -
Uploaded on

August 23, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00480090

English

Eligibility Prostate Cancer NCT00480090

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
biopsy-proven prostate cancer or clinical picture consistent with metastatic prostate cancer with high level of serum psa (> 20ng/ml)
Description

Prostate carcinoma Biopsy | Secondary malignant neoplasm of prostate | Serum PSA Increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0005558
UMLS CUI [2]
C0347001
UMLS CUI [3]
C1883014
at least 4 weeks after docetaxel treatment and have at least 2 consecutive rising psas measured at least 2 weeks apart
Description

Docetaxel | Serum Prostate Specific Antigen Increased Measurement Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0246415
UMLS CUI [2,1]
C1883014
UMLS CUI [2,2]
C0242485
UMLS CUI [2,3]
C1265611
progression on or intolerance of docetaxel chemotherapy
Description

Docetaxel | Disease Progression | Intolerance to docetaxel

Data type

boolean

Alias
UMLS CUI [1]
C0246415
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0246415
ecog performance status ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ and marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with cytarabine
Description

Cytarabine

Data type

boolean

Alias
UMLS CUI [1]
C0010711
receiving any other investigational or anticancer agents
Description

Investigational New Drugs | Antineoplastic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0003392
uncontrolled intercurrent illness
Description

Comorbidity Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
active malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin
Description

Malignant Neoplasm Site Other | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0553723
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
radiotherapy within the past 4 weeks
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
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Similar models

Eligibility Prostate Cancer NCT00480090

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma Biopsy | Secondary malignant neoplasm of prostate | Serum PSA Increased
Item
biopsy-proven prostate cancer or clinical picture consistent with metastatic prostate cancer with high level of serum psa (> 20ng/ml)
boolean
C0600139 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0347001 (UMLS CUI [2])
C1883014 (UMLS CUI [3])
Docetaxel | Serum Prostate Specific Antigen Increased Measurement Quantity
Item
at least 4 weeks after docetaxel treatment and have at least 2 consecutive rising psas measured at least 2 weeks apart
boolean
C0246415 (UMLS CUI [1])
C1883014 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Docetaxel | Disease Progression | Intolerance to docetaxel
Item
progression on or intolerance of docetaxel chemotherapy
boolean
C0246415 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C1744706 (UMLS CUI [3,1])
C0246415 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
adequate organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cytarabine
Item
prior treatment with cytarabine
boolean
C0010711 (UMLS CUI [1])
Investigational New Drugs | Antineoplastic Agents
Item
receiving any other investigational or anticancer agents
boolean
C0013230 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
Comorbidity Uncontrolled
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Malignant Neoplasm Site Other | Exception Squamous cell carcinoma of skin | Exception Basal cell carcinoma
Item
active malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin
boolean
C0006826 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0553723 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
Therapeutic radiology procedure
Item
radiotherapy within the past 4 weeks
boolean
C1522449 (UMLS CUI [1])
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