ID

12845

Description

A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00001266

Link

https://clinicaltrials.gov/show/NCT00001266

Keywords

Versions (1)
  1. 12/29/15 12/29/15 -
Uploaded on

December 29, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasm NCT00001266

English

Eligibility Prostatic Neoplasm NCT00001266

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.
Description

patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.

Data type

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0392920
patients must be 18 years of age
Description

patients must be 18 years of age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
an sgot/sgpt within 2 times of normal.
Description

an sgot/sgpt within 2 times of normal.

Data type

boolean

Alias
UMLS CUI [1]
C0001899
UMLS CUI [2]
C0004002
patients must have stage d2 prostate carcinoma or state d1 disease with a gleason grade 7 or above (poorly differentiated).
Description

patients must have stage d2 prostate carcinoma or state d1 disease with a gleason grade 7 or above (poorly differentiated).

Data type

boolean

Alias
UMLS CUI [1]
C0027646
UMLS CUI [2]
C0332332
no other malignancy except curatively treated basal cell cancer of the skin.
Description

no other malignancy except curatively treated basal cell cancer of the skin.

Data type

boolean

Alias
UMLS CUI [1]
C0006826
performance status ecog of 0-3.
Description

performance status ecog of 0-3.

Data type

boolean

Alias
UMLS CUI [1]
C1520224
ability to give informed consent.
Description

ability to give informed consent.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
no history of bleeding diathesis. patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.
Description

no history of bleeding diathesis. patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0030920
no history of cerebrovascular event, either thrombotic or hemorrhagic.
Description

no history of cerebrovascular event, either thrombotic or hemorrhagic.

Data type

boolean

Alias
UMLS CUI [1]
C0852396
no current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. patient cannot be on calcium channel blockers such as nifedipine, diltiazem, or verapamil.
Description

no current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. patient cannot be on calcium channel blockers such as nifedipine, diltiazem, or verapamil.

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0006684
no clinical or radiographic evidence of brain metastases.
Description

no clinical or radiographic evidence of brain metastases.

Data type

boolean

Alias
UMLS CUI [1]
C0220650
patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.
Description

patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.

Data type

boolean

Alias
UMLS CUI [1,1]
C1883411
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0205231
patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.
Description

patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0010294
patients must have adequate hepatic function (bilirubin less than 1.5mg%).
Description

patients must have adequate hepatic function (bilirubin less than 1.5mg%).

Data type

boolean

Alias
UMLS CUI [1]
C1278039
if the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.
Description

if the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.

Data type

boolean

Alias
UMLS CUI [1]
C0042029
patients must not have received chemotherapy.
Description

patients must not have received chemotherapy.

Data type

boolean

Alias
UMLS CUI [1]
C0392920
an absolute granulocyte count greater than 1,500; platelet count greater than 100,000; fibrinogen greater than 200 mg/dl; hgb greater than or equal to 9 gm/dl.
Description

an absolute granulocyte count greater than 1,500; platelet count greater than 100,000; fibrinogen greater than 200 mg/dl; hgb greater than or equal to 9 gm/dl.

Data type

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0005821
UMLS CUI [3]
C0016006
UMLS CUI [4]
C0019046
reliability of the patient to take oral medication, go home and return for follow-up and treatment.
Description

reliability of the patient to take oral medication, go home and return for follow-up and treatment.

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Prostatic Neoplasm NCT00001266

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
carcinoma of the prostate
Item
patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.
boolean
C0600139 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
age
Item
patients must be 18 years of age
boolean
C0001779 (UMLS CUI [1])
ALT and AST
Item
an sgot/sgpt within 2 times of normal.
boolean
C0001899 (UMLS CUI [1])
C0004002 (UMLS CUI [2])
tumor staging
Item
patients must have stage d2 prostate carcinoma or state d1 disease with a gleason grade 7 or above (poorly differentiated).
boolean
C0027646 (UMLS CUI [1])
C0332332 (UMLS CUI [2])
other malignancy
Item
no other malignancy except curatively treated basal cell cancer of the skin.
boolean
C0006826 (UMLS CUI [1])
performance status
Item
performance status ecog of 0-3.
boolean
C1520224 (UMLS CUI [1])
informed consent
Item
ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
bleeding diathesis
Item
no history of bleeding diathesis. patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study.
boolean
C0005779 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
cerebrovascular event
Item
no history of cerebrovascular event, either thrombotic or hemorrhagic.
boolean
C0852396 (UMLS CUI [1])
congestive heart failure
Item
no current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. patient cannot be on calcium channel blockers such as nifedipine, diltiazem, or verapamil.
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0006684 (UMLS CUI [4])
brain metastases
Item
no clinical or radiographic evidence of brain metastases.
boolean
C0220650 (UMLS CUI [1])
extensive liver replacement
Item
patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.
boolean
C1883411 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205231 (UMLS CUI [1,3])
creatinine
Item
patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.
boolean
C0201976 (UMLS CUI [1])
C0010294 (UMLS CUI [2])
hepatic function
Item
patients must have adequate hepatic function (bilirubin less than 1.5mg%).
boolean
C1278039 (UMLS CUI [1])
urinalysis
Item
if the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.
boolean
C0042029 (UMLS CUI [1])
chemotherapy
Item
patients must not have received chemotherapy.
boolean
C0392920 (UMLS CUI [1])
blood results
Item
an absolute granulocyte count greater than 1,500; platelet count greater than 100,000; fibrinogen greater than 200 mg/dl; hgb greater than or equal to 9 gm/dl.
boolean
C0857490 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
C0016006 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
patient compliance
Item
reliability of the patient to take oral medication, go home and return for follow-up and treatment.
boolean
C1321605 (UMLS CUI [1])
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