ID

22265

Description

Trial of GM-CSF Given in Combination With Ketoconazole and Mitoxantrone in Patients With Progressive Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00447473

Link

https://clinicaltrials.gov/show/NCT00447473

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 Prostatic Neoplasms NCT00447473

English

Eligibility Prostatic Neoplasms NCT00447473

1 forms  
Criteria
Description

Criteria

testosterone < 50 ng/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

progressive disease after androgen deprivation

Data type

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0279492
patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen.
Description

antiandrogen discontinuation disease progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0002842
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0242656
karnofsky performance status ≥ 60%.
Description

karnofsky performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
one prior taxane based chemotherapy for prostate cancer. no more than two prior systemic therapies. at least four weeks have lapsed since prior therapy.
Description

prostate cancer taxane based chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C3541958
patients may have had prior ketoconazole, aminoglutethimide or corticosteroids for treatment of progressive prostate cancer.
Description

ketoconazole, aminoglutethimide, corticosteroids

Data type

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2]
C0002555
UMLS CUI [3]
C0001617
patients receiving any other hormonal therapy, including any dose of megestrol acetate (megace), proscar (finasteride), any herbal product known to decrease psa levels (e.g., saw palmetto and pc-spes), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment. progressive disease must be documented after discontinuation of the hormonal therapy.
Description

hormonal therapy, progressive disease documentation

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2,1]
C0677932
UMLS CUI [2,2]
C0920316
patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
Description

bisphosphonates

Data type

boolean

Alias
UMLS CUI [1]
C0012544
liver function tests (alt, ast) less than 1.5 x upper limit of normal (uln). the bilirubin must be within normal limits.
Description

liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0201913
UMLS CUI [1,3]
C0201836
UMLS CUI [1,4]
C0201899
anc >1500/µl, platelet count > 100,00/µl, creatinine <1.5 x uln, hemoglobin > 8 mg/dl
Description

anc, platelet count, creatinine, hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0019046
ejection fraction ≥45%.
Description

cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
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Similar models

Eligibility Prostatic Neoplasms NCT00447473

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
testosterone, androgen deprivation
Item
testosterone < 50 ng/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])
progressive disease after androgen deprivation
Item
progressive disease after androgen deprivation.
boolean
C1335499 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
antiandrogen discontinuation disease progression
Item
patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen.
boolean
C0002842 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0242656 (UMLS CUI [1,3])
karnofsky performance status
Item
karnofsky performance status ≥ 60%.
boolean
C0206065 (UMLS CUI [1])
prostate cancer taxane based chemotherapy
Item
one prior taxane based chemotherapy for prostate cancer. no more than two prior systemic therapies. at least four weeks have lapsed since prior therapy.
boolean
C0600139 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C3541958 (UMLS CUI [1,3])
ketoconazole, aminoglutethimide, corticosteroids
Item
patients may have had prior ketoconazole, aminoglutethimide or corticosteroids for treatment of progressive prostate cancer.
boolean
C0022625 (UMLS CUI [1])
C0002555 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
hormonal therapy, progressive disease documentation
Item
patients receiving any other hormonal therapy, including any dose of megestrol acetate (megace), proscar (finasteride), any herbal product known to decrease psa levels (e.g., saw palmetto and pc-spes), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment. progressive disease must be documented after discontinuation of the hormonal therapy.
boolean
C0279025 (UMLS CUI [1])
C0677932 (UMLS CUI [2,1])
C0920316 (UMLS CUI [2,2])
bisphosphonates
Item
patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
boolean
C0012544 (UMLS CUI [1])
liver function
Item
liver function tests (alt, ast) less than 1.5 x upper limit of normal (uln). the bilirubin must be within normal limits.
boolean
C0232741 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,3])
C0201899 (UMLS CUI [1,4])
anc, platelet count, creatinine, hemoglobin
Item
anc >1500/µl, platelet count > 100,00/µl, creatinine <1.5 x uln, hemoglobin > 8 mg/dl
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
cardiac ejection fraction
Item
ejection fraction ≥45%.
boolean
C0232174 (UMLS CUI [1])
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