ID

22263

Description

Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00585416

Link

https://clinicaltrials.gov/show/NCT00585416

Keywords

Versions (1)
  1. 5/27/17 5/27/17 -
Uploaded on

May 27, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00585416

English

Eligibility Prostate Cancer NCT00585416

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
metastatic hormone refractory prostate cancer.
Description

metastatic hormone refractory prostate cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0936223
UMLS CUI [1,2]
C1328504
eastern cooperative oncology group (ecog) performance status of 0-1.
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
testosterone <50ng/dl. patients must continue primary androgen deprivation with an lhrh analogue if they have not undergone orchiectomy.
Description

testosterone, androgen deprivation

Data type

boolean

Alias
UMLS CUI [1]
C0039601
UMLS CUI [2]
C0279492
progressive disease after androgen deprivation.
Description

disease progression after androgen deprivation

Data type

boolean

Alias
UMLS CUI [1]
C1328504
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients whose clinical condition would make chemotherapy clearly indicated.
Description

chemotherapy indicated by patient condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1444656
UMLS CUI [1,3]
C0683521
patients who have received systemic chemotherapy for the treatment of metastatic disease.
Description

systemic chemotherapy for metastatic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0027627
peripheral neuropathy > grade 1
Description

peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
prior anti-angiogenic therapy, including thalidomide.
Description

anti-angiogenic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0596087
patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry.
Description

surgery recovery, prior major surgery or radiation

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2004454
UMLS CUI [2]
C0679637
UMLS CUI [3]
C1522449
patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
Description

radiopharmaceuticals

Data type

boolean

Alias
UMLS CUI [1]
C0182638
patients with known brain metastases or history of brain metastases.
Description

brain metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0220650
history of stroke within 6 months of treatment or other significant neurological limitations.
Description

surgery recovery, neurological limitations

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0027765
patients who have received more than 2 prior investigational treatments.
Description

investigational treatment

Data type

boolean

Alias
UMLS CUI [1]
C0949266
uncontrolled intercurrent illness
Description

comorbidities

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias
Description

myocardial infarction, hospitalizations for congestive heart failure, cardiac arrhythmias

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C0019993
UMLS CUI [3]
C0003811
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Similar models

Eligibility Prostate Cancer NCT00585416

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
metastatic hormone refractory prostate cancer
Item
metastatic hormone refractory prostate cancer.
boolean
C0936223 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
ecog
Item
eastern cooperative oncology group (ecog) performance status of 0-1.
boolean
C1520224 (UMLS CUI [1])
testosterone, androgen deprivation
Item
testosterone <50ng/dl. patients must continue primary androgen deprivation with an lhrh analogue if they have not undergone orchiectomy.
boolean
C0039601 (UMLS CUI [1])
C0279492 (UMLS CUI [2])
disease progression after androgen deprivation
Item
progressive disease after androgen deprivation.
boolean
C1328504 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
chemotherapy indicated by patient condition
Item
patients whose clinical condition would make chemotherapy clearly indicated.
boolean
C0392920 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])
C0683521 (UMLS CUI [1,3])
systemic chemotherapy for metastatic disease
Item
patients who have received systemic chemotherapy for the treatment of metastatic disease.
boolean
C1883256 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
peripheral neuropathy
Item
peripheral neuropathy > grade 1
boolean
C0031117 (UMLS CUI [1])
anti-angiogenic therapy
Item
prior anti-angiogenic therapy, including thalidomide.
boolean
C0596087 (UMLS CUI [1])
surgery recovery, prior major surgery or radiation
Item
patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry.
boolean
C0543467 (UMLS CUI [1,1])
C2004454 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
radiopharmaceuticals
Item
patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
boolean
C0182638 (UMLS CUI [1])
brain metastasis
Item
patients with known brain metastases or history of brain metastases.
boolean
C0220650 (UMLS CUI [1])
surgery recovery, neurological limitations
Item
history of stroke within 6 months of treatment or other significant neurological limitations.
boolean
C0038454 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
investigational treatment
Item
patients who have received more than 2 prior investigational treatments.
boolean
C0949266 (UMLS CUI [1])
comorbidities
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1])
myocardial infarction, hospitalizations for congestive heart failure, cardiac arrhythmias
Item
patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3])
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