ID

22260

Description

Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC); ODM derived from: https://clinicaltrials.gov/show/NCT00307294

Link

https://clinicaltrials.gov/show/NCT00307294

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 NCT00307294

English

Eligibility Prostate Cancer NCT00307294

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the prostate.
Description

ID.1

Data type

boolean

confirmed androgen independent prostate cancer with evidence of rising psa (two successive increases in psa, at least 4 weeks apart) while on chemotherapy. if the psa is less than 5, the increase in psa must be at least 50%. must also have castrate testosterone levels (<50 ng/ml)
Description

androgen independent prostate cancer, psa and testosterone level

Data type

boolean

Alias
UMLS CUI [1,1]
C1654637
UMLS CUI [1,2]
C0201544
UMLS CUI [1,3]
C0039601
patients could not have received more than 2 previous chemotherapy regimens.
Description

previous chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
no anthracyclines within the past 6 months.
Description

anthracyclines

Data type

boolean

Alias
UMLS CUI [1]
C0282564
no prior single agent thalidomide in the last 12 months. no prior cytotoxic chemotherapy + thalidomide given in conjunction
Description

thalidomide

Data type

boolean

Alias
UMLS CUI [1]
C0039736
age > 18 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
performance status ecog 0-2
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
peripheral neuropathy must be < grade 1
Description

peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
must have adequate hematologic, hepatic and renal function
Description

hematologic, hepatic, renal function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
men of reproductive potential must be willing to consent to using effective contraception while on treatment and for at least 4 weeks thereafter
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
patients must have left ventricular ejection fraction of > 50% within 42 days prior to first dose of study drug. the method used at baseline must be used for later monitoring
Description

left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
must have been off an anti-androgen for at least 4-6 weeks (flutamide and bicalutamide respectively) and documented as having a rising psa
Description

anti-androgen, psa

Data type

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2]
C0138741
measurable or evaluable disease (psa elevation will constitute evaluable disease). measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques ct scan or as >10 mm with spiral ct scan. see section 6.b for the evaluation of measurable disease
Description

prostate cancer, measurable disease, evaluable disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0376358
UMLS CUI [1,2]
C1513041
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0376358
UMLS CUI [2,2]
C1516986
UMLS CUI [2,3]
C0138741
life expectancy of greater than 3 months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients must be willing and able to comply with the fda-mandated s.t.e.p.s.® program
Description

fda evaluation program thalidomide

Data type

boolean

Alias
UMLS CUI [1,1]
C0041714
UMLS CUI [1,2]
C0162696
UMLS CUI [1,3]
C0039736
ability to understand and sign written informed consent approved by the institutional review board [irb/ethics committee], which will be obtained prior to study entry.
Description

informed consent, ethics committee

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0086911
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with unstable angina, uncompensated chf, a history of an mi, pe or dvt within the last 3 months
Description

unstable angina, congestive heart failure, myocardial infarction, pulmonary embolism, deep vein thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0034065
UMLS CUI [5]
C0149871
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Similar models

Eligibility Prostate Cancer NCT00307294

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
histologically or cytologically confirmed adenocarcinoma of the prostate.
boolean
androgen independent prostate cancer, psa and testosterone level
Item
confirmed androgen independent prostate cancer with evidence of rising psa (two successive increases in psa, at least 4 weeks apart) while on chemotherapy. if the psa is less than 5, the increase in psa must be at least 50%. must also have castrate testosterone levels (<50 ng/ml)
boolean
C1654637 (UMLS CUI [1,1])
C0201544 (UMLS CUI [1,2])
C0039601 (UMLS CUI [1,3])
previous chemotherapy
Item
patients could not have received more than 2 previous chemotherapy regimens.
boolean
C0392920 (UMLS CUI [1])
anthracyclines
Item
no anthracyclines within the past 6 months.
boolean
C0282564 (UMLS CUI [1])
thalidomide
Item
no prior single agent thalidomide in the last 12 months. no prior cytotoxic chemotherapy + thalidomide given in conjunction
boolean
C0039736 (UMLS CUI [1])
age
Item
age > 18 years of age
boolean
C0001779 (UMLS CUI [1])
ecog
Item
performance status ecog 0-2
boolean
C1520224 (UMLS CUI [1])
peripheral neuropathy
Item
peripheral neuropathy must be < grade 1
boolean
C0031117 (UMLS CUI [1])
hematologic, hepatic, renal function
Item
must have adequate hematologic, hepatic and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
contraception
Item
men of reproductive potential must be willing to consent to using effective contraception while on treatment and for at least 4 weeks thereafter
boolean
C0700589 (UMLS CUI [1])
left ventricular ejection fraction
Item
patients must have left ventricular ejection fraction of > 50% within 42 days prior to first dose of study drug. the method used at baseline must be used for later monitoring
boolean
C0428772 (UMLS CUI [1])
anti-androgen, psa
Item
must have been off an anti-androgen for at least 4-6 weeks (flutamide and bicalutamide respectively) and documented as having a rising psa
boolean
C0279492 (UMLS CUI [1])
C0138741 (UMLS CUI [2])
prostate cancer, measurable disease, evaluable disease
Item
measurable or evaluable disease (psa elevation will constitute evaluable disease). measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques ct scan or as >10 mm with spiral ct scan. see section 6.b for the evaluation of measurable disease
boolean
C0376358 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0376358 (UMLS CUI [2,1])
C1516986 (UMLS CUI [2,2])
C0138741 (UMLS CUI [2,3])
life expectancy
Item
life expectancy of greater than 3 months
boolean
C0023671 (UMLS CUI [1])
fda evaluation program thalidomide
Item
patients must be willing and able to comply with the fda-mandated s.t.e.p.s.® program
boolean
C0041714 (UMLS CUI [1,1])
C0162696 (UMLS CUI [1,2])
C0039736 (UMLS CUI [1,3])
informed consent, ethics committee
Item
ability to understand and sign written informed consent approved by the institutional review board [irb/ethics committee], which will be obtained prior to study entry.
boolean
C0021430 (UMLS CUI [1,1])
C0086911 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
unstable angina, congestive heart failure, myocardial infarction, pulmonary embolism, deep vein thrombosis
Item
patients with unstable angina, uncompensated chf, a history of an mi, pe or dvt within the last 3 months
boolean
C0002965 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0034065 (UMLS CUI [4])
C0149871 (UMLS CUI [5])
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