ID

18125

Description

Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00494338

Link

https://clinicaltrials.gov/show/NCT00494338

Keywords

Versions (1)
  1. 10/21/16 10/21/16 -
Uploaded on

October 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Prostate Cancer NCT00494338

English

Eligibility Metastatic Prostate Cancer NCT00494338

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed maipc
Description

Androgen Insensitive Prostatic Neoplasms Metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C3658267
UMLS CUI [1,2]
C0036525
documented progressive disease in bone, soft tissue or psa despite castrate levels of testosterone
Description

Progressive Disease bone | Progressive Disease soft tissue | Prostate-Specific Antigen | Testosterone level

Data type

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0262950
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C0225317
UMLS CUI [3]
C0138741
UMLS CUI [4]
C0428412
if lhrh agonist were used previously it must be kept
Description

Luteinizing Hormone-releasing Hormone Agonist

Data type

boolean

Alias
UMLS CUI [1]
C1518041
previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida
Description

Androgen Antagonists | Flutamide | Cyproterone

Data type

boolean

Alias
UMLS CUI [1]
C0002842
UMLS CUI [2]
C0016384
UMLS CUI [3]
C0010621
previous des should be held for at least 4 weeks before partcipating in the trial
Description

Diethylstilbestrol

Data type

boolean

Alias
UMLS CUI [1]
C0012203
chemotherapy naive patients
Description

Chemotherapy naive

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0919936
no prior radioisotope
Description

Radioisotopes

Data type

boolean

Alias
UMLS CUI [1]
C0034595
less than 25% of bone marrow should be irradiated for prior palliative radiotherapy
Description

Palliative course of radiotherapy Bone Marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0475092
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
kps> 70%
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
adequate hematologic, hepatic and renal function
Description

Hematologic function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with serious medical illness
Description

Illness Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
history of significant active cardiac disease
Description

Heart Disease Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0750502
history of gastrointestinal ulceration, bleeding or perforation
Description

Gastrointestinal ulceration | Gastrointestinal Hemorrhage | Gastrointestinal perforation

Data type

boolean

Alias
UMLS CUI [1]
C1963975
UMLS CUI [2]
C0017181
UMLS CUI [3]
C0151664
history of myocardial infarctin within past 12 months
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
allergy to sulfonamides or to celecoxib or history of urticaria to any nsaid
Description

Allergy to sulfonamides | Hypersensitivity celecoxib | Urticaria Due to NSAIDS

Data type

boolean

Alias
UMLS CUI [1]
C0038757
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0538927
UMLS CUI [3,1]
C0042109
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0003211
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Metastatic Prostate Cancer NCT00494338

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Androgen Insensitive Prostatic Neoplasms Metastatic
Item
patients with histologically confirmed maipc
boolean
C3658267 (UMLS CUI [1,1])
C0036525 (UMLS CUI [1,2])
Progressive Disease bone | Progressive Disease soft tissue | Prostate-Specific Antigen | Testosterone level
Item
documented progressive disease in bone, soft tissue or psa despite castrate levels of testosterone
boolean
C1335499 (UMLS CUI [1,1])
C0262950 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2,1])
C0225317 (UMLS CUI [2,2])
C0138741 (UMLS CUI [3])
C0428412 (UMLS CUI [4])
Luteinizing Hormone-releasing Hormone Agonist
Item
if lhrh agonist were used previously it must be kept
boolean
C1518041 (UMLS CUI [1])
Androgen Antagonists | Flutamide | Cyproterone
Item
previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida
boolean
C0002842 (UMLS CUI [1])
C0016384 (UMLS CUI [2])
C0010621 (UMLS CUI [3])
Diethylstilbestrol
Item
previous des should be held for at least 4 weeks before partcipating in the trial
boolean
C0012203 (UMLS CUI [1])
Chemotherapy naive
Item
chemotherapy naive patients
boolean
C3665472 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Radioisotopes
Item
no prior radioisotope
boolean
C0034595 (UMLS CUI [1])
Palliative course of radiotherapy Bone Marrow Percentage
Item
less than 25% of bone marrow should be irradiated for prior palliative radiotherapy
boolean
C0475092 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Karnofsky Performance Status
Item
kps> 70%
boolean
C0206065 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
adequate hematologic, hepatic and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Illness Serious
Item
patients with serious medical illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Heart Disease Significant
Item
history of significant active cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Gastrointestinal ulceration | Gastrointestinal Hemorrhage | Gastrointestinal perforation
Item
history of gastrointestinal ulceration, bleeding or perforation
boolean
C1963975 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0151664 (UMLS CUI [3])
Myocardial Infarction
Item
history of myocardial infarctin within past 12 months
boolean
C0027051 (UMLS CUI [1])
Allergy to sulfonamides | Hypersensitivity celecoxib | Urticaria Due to NSAIDS
Item
allergy to sulfonamides or to celecoxib or history of urticaria to any nsaid
boolean
C0038757 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0538927 (UMLS CUI [2,2])
C0042109 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0003211 (UMLS CUI [3,3])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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