ID

19017

Description

Study of Oxaliplatin and Taxotere in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00260611

Lien

https://clinicaltrials.gov/show/NCT00260611

Mots-clés

Versions (1)
  1. 30/11/2016 30/11/2016 -
Téléchargé le

30 novembre 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00260611

Anglais

Eligibility Prostate Cancer NCT00260611

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have histologically or cytologically confirmed adenocarcinoma consistent clinically and histologically with carcinoma of the prostate confirmed androgen independent prostate cancer (progression despite castrate levels of serum testosterone) measurable or evaluable disease (psa elevation will constitute evaluable disease) 18 years of age. because no dosing or adverse event data are currently available on the use of oxaliplatin in patients < 18 years of age, they are excluded from this study.
Description

Adenocarcinoma | Prostate carcinoma | androgen independent prostate cancer | Serum testosterone measurement Level Decreased | Disease Progression | Measurable Disease | Evaluable Disease | Raised prostate specific antigen | Age | oxaliplatin

Type de données

boolean

Alias
UMLS CUI [1]
C0001418
UMLS CUI [2]
C0600139
UMLS CUI [3]
C1654637
UMLS CUI [4,1]
C0428413
UMLS CUI [4,2]
C0441889
UMLS CUI [4,3]
C0205216
UMLS CUI [5]
C0242656
UMLS CUI [6]
C1513041
UMLS CUI [7]
C1516986
UMLS CUI [8]
C0178415
UMLS CUI [9]
C0001779
UMLS CUI [10]
C0069717
life expectancy of greater than 3 months. ecog performance status of 0-1. no more than 2 prior regimens of cytotoxic chemotherapy. androgen deprivation (castration or lhrh analogue), and prior antiandrogens allowed.
Description

Life Expectancy | ECOG performance status | Cytotoxic Chemotherapy Quantity | androgen suppression | Male Castration | Luteinizing Hormone-releasing Hormone Agonist | Androgen Antagonists

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C1520224
UMLS CUI [3,1]
C0677881
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C1515985
UMLS CUI [5]
C0007347
UMLS CUI [6]
C1518041
UMLS CUI [7]
C0002842
patients must be off bicalutamide or nilutamide > 42 days, megestrol or flutamide > 28 days.
Description

bicalutamide Discontinued | nilutamide Discontinued | Megestrol Discontinued | Flutamide Discontinued

Type de données

boolean

Alias
UMLS CUI [1,1]
C0285590
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0068771
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0025175
UMLS CUI [3,2]
C1444662
UMLS CUI [4,1]
C0016384
UMLS CUI [4,2]
C1444662
concurrent bisphosphonate therapy allowed. patients with prior radiotherapy for treatment of their bony metastases will be included if time since radiation is > 4 weeks, and if psa is clearly rising.
Description

Diphosphonates | Therapeutic radiology procedure Secondary malignant neoplasm of bone | Raised prostate specific antigen

Type de données

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0153690
UMLS CUI [3]
C0178415
patients must have acceptable organ function as defined as: :wbc > 2500/mm3 or anc > 1500/mm3, hemoglobin > 9.0 g/dl, platelet count > 100,000/mm3; bilirubin < 1.5 mg/dl, sgot/sgpt < 2 x uln (< 4 x uln if liver metastases present), pt/ptt normal; creatinine < 1.8 mg/dl adequate neurologic function defined as no clinically significant peripheral neuropathy, defined as any neuropathy ≤ grade 1.
Description

Organ function | White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Prothrombin time normal | Partial Thromboplastin Time measurement | Creatinine measurement, serum | Neurologic function | Peripheral Neuropathy Clinical Significance | Neuropathy CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0019046
UMLS CUI [5]
C0032181
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201836
UMLS CUI [9]
C0494165
UMLS CUI [10]
C0580551
UMLS CUI [11]
C0030605
UMLS CUI [12]
C0201976
UMLS CUI [13]
C0027767
UMLS CUI [14,1]
C0031117
UMLS CUI [14,2]
C2826293
UMLS CUI [15,1]
C0442874
UMLS CUI [15,2]
C1516728
adequate cardiovascular function defined as no active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months.
Description

Normal cardiovascular function | Congestive heart failure | Angina Pectoris Uncontrolled | Myocardial Infarction

Type de données

boolean

Alias
UMLS CUI [1]
C0232089
UMLS CUI [2]
C0018802
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0027051
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no other experimental treatment, cytotoxics or radiation 4 weeks prior to enrollment. may not be taking other investigational drugs while on trial.
Description

Therapies, Investigational | Cytotoxic Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2]
C0677881
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0013230
patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Description

Metastatic malignant neoplasm to brain | Prognosis bad | Progressive neurologic dysfunction Interferes with Event Neurologic | Progressive neurologic dysfunction Interferes with Adverse event

Type de données

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0278252
UMLS CUI [3,1]
C4013375
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0441471
UMLS CUI [3,4]
C0205494
UMLS CUI [4,1]
C4013375
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0877248
no prior therapy with oxaliplatin is allowed. no history of allergic reactions attributed to the drugs used in this study or compounds of similar chemical or biologic composition.
Description

oxaliplatin | Allergic Reaction Investigational New Drugs | Allergic Reaction Compound Similar

Type de données

boolean

Alias
UMLS CUI [1]
C0069717
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C1706082
UMLS CUI [3,3]
C2348205
no history of intolerance or allergy to the antiemetics to be administered in conjunction with the study drugs (i.e., 5 ht3 antagonists).
Description

intolerance to Antiemetics | Hypersensitivity Antiemetics | Investigational New Drugs | intolerance to 5-HT>3< receptor antagonist | Hypersensitivity 5-HT>3< receptor antagonist

Type de données

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0003297
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0003297
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0360055
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0360055
no concurrent other active cancer from another primary site, except squamous cell and basal cell carcinoma of the skin.
Description

Malignant Neoplasm Site Primary | Squamous cell carcinoma of skin | Basal cell carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205225
UMLS CUI [2]
C0553723
UMLS CUI [3]
C0007117
no other serious concomitant illness will be allowed, including interstitial pneumonia, extensive and symptomatic fibrosis of the lung, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, nyha class iii or iv, serious cardiac arrhythmia, uncontrolled diabetes mellitus or active infection.
Description

Comorbidity | Pneumonia, Interstitial | Pulmonary Fibrosis Extensive Symptomatic | Uncontrolled hypertension | Angina, Unstable | Symptomatic congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious | Diabetic - poor control | Communicable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0206061
UMLS CUI [3,1]
C0034069
UMLS CUI [3,2]
C0205231
UMLS CUI [3,3]
C0231220
UMLS CUI [4]
C1868885
UMLS CUI [5]
C0002965
UMLS CUI [6,1]
C0742758
UMLS CUI [6,2]
C1275491
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C0205404
UMLS CUI [8]
C0421258
UMLS CUI [9]
C0009450
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Similar models

Eligibility Prostate Cancer NCT00260611

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma | Prostate carcinoma | androgen independent prostate cancer | Serum testosterone measurement Level Decreased | Disease Progression | Measurable Disease | Evaluable Disease | Raised prostate specific antigen | Age | oxaliplatin
Item
must have histologically or cytologically confirmed adenocarcinoma consistent clinically and histologically with carcinoma of the prostate confirmed androgen independent prostate cancer (progression despite castrate levels of serum testosterone) measurable or evaluable disease (psa elevation will constitute evaluable disease) 18 years of age. because no dosing or adverse event data are currently available on the use of oxaliplatin in patients < 18 years of age, they are excluded from this study.
boolean
C0001418 (UMLS CUI [1])
C0600139 (UMLS CUI [2])
C1654637 (UMLS CUI [3])
C0428413 (UMLS CUI [4,1])
C0441889 (UMLS CUI [4,2])
C0205216 (UMLS CUI [4,3])
C0242656 (UMLS CUI [5])
C1513041 (UMLS CUI [6])
C1516986 (UMLS CUI [7])
C0178415 (UMLS CUI [8])
C0001779 (UMLS CUI [9])
C0069717 (UMLS CUI [10])
Life Expectancy | ECOG performance status | Cytotoxic Chemotherapy Quantity | androgen suppression | Male Castration | Luteinizing Hormone-releasing Hormone Agonist | Androgen Antagonists
Item
life expectancy of greater than 3 months. ecog performance status of 0-1. no more than 2 prior regimens of cytotoxic chemotherapy. androgen deprivation (castration or lhrh analogue), and prior antiandrogens allowed.
boolean
C0023671 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
C0677881 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1515985 (UMLS CUI [4])
C0007347 (UMLS CUI [5])
C1518041 (UMLS CUI [6])
C0002842 (UMLS CUI [7])
bicalutamide Discontinued | nilutamide Discontinued | Megestrol Discontinued | Flutamide Discontinued
Item
patients must be off bicalutamide or nilutamide > 42 days, megestrol or flutamide > 28 days.
boolean
C0285590 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0068771 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0025175 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0016384 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
Diphosphonates | Therapeutic radiology procedure Secondary malignant neoplasm of bone | Raised prostate specific antigen
Item
concurrent bisphosphonate therapy allowed. patients with prior radiotherapy for treatment of their bony metastases will be included if time since radiation is > 4 weeks, and if psa is clearly rising.
boolean
C0012544 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0153690 (UMLS CUI [2,2])
C0178415 (UMLS CUI [3])
Organ function | White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver | Prothrombin time normal | Partial Thromboplastin Time measurement | Creatinine measurement, serum | Neurologic function | Peripheral Neuropathy Clinical Significance | Neuropathy CTCAE Grades
Item
patients must have acceptable organ function as defined as: :wbc > 2500/mm3 or anc > 1500/mm3, hemoglobin > 9.0 g/dl, platelet count > 100,000/mm3; bilirubin < 1.5 mg/dl, sgot/sgpt < 2 x uln (< 4 x uln if liver metastases present), pt/ptt normal; creatinine < 1.8 mg/dl adequate neurologic function defined as no clinically significant peripheral neuropathy, defined as any neuropathy ≤ grade 1.
boolean
C0678852 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0494165 (UMLS CUI [9])
C0580551 (UMLS CUI [10])
C0030605 (UMLS CUI [11])
C0201976 (UMLS CUI [12])
C0027767 (UMLS CUI [13])
C0031117 (UMLS CUI [14,1])
C2826293 (UMLS CUI [14,2])
C0442874 (UMLS CUI [15,1])
C1516728 (UMLS CUI [15,2])
Normal cardiovascular function | Congestive heart failure | Angina Pectoris Uncontrolled | Myocardial Infarction
Item
adequate cardiovascular function defined as no active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months.
boolean
C0232089 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Therapies, Investigational | Cytotoxic Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs
Item
no other experimental treatment, cytotoxics or radiation 4 weeks prior to enrollment. may not be taking other investigational drugs while on trial.
boolean
C0949266 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Metastatic malignant neoplasm to brain | Prognosis bad | Progressive neurologic dysfunction Interferes with Event Neurologic | Progressive neurologic dysfunction Interferes with Adverse event
Item
patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
boolean
C0220650 (UMLS CUI [1])
C0278252 (UMLS CUI [2])
C4013375 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0441471 (UMLS CUI [3,3])
C0205494 (UMLS CUI [3,4])
C4013375 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0877248 (UMLS CUI [4,3])
oxaliplatin | Allergic Reaction Investigational New Drugs | Allergic Reaction Compound Similar
Item
no prior therapy with oxaliplatin is allowed. no history of allergic reactions attributed to the drugs used in this study or compounds of similar chemical or biologic composition.
boolean
C0069717 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C1706082 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
intolerance to Antiemetics | Hypersensitivity Antiemetics | Investigational New Drugs | intolerance to 5-HT>3< receptor antagonist | Hypersensitivity 5-HT>3< receptor antagonist
Item
no history of intolerance or allergy to the antiemetics to be administered in conjunction with the study drugs (i.e., 5 ht3 antagonists).
boolean
C1744706 (UMLS CUI [1,1])
C0003297 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0003297 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0360055 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0360055 (UMLS CUI [5,2])
Malignant Neoplasm Site Primary | Squamous cell carcinoma of skin | Basal cell carcinoma
Item
no concurrent other active cancer from another primary site, except squamous cell and basal cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0553723 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
Comorbidity | Pneumonia, Interstitial | Pulmonary Fibrosis Extensive Symptomatic | Uncontrolled hypertension | Angina, Unstable | Symptomatic congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious | Diabetic - poor control | Communicable Disease
Item
no other serious concomitant illness will be allowed, including interstitial pneumonia, extensive and symptomatic fibrosis of the lung, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, nyha class iii or iv, serious cardiac arrhythmia, uncontrolled diabetes mellitus or active infection.
boolean
C0009488 (UMLS CUI [1])
C0206061 (UMLS CUI [2])
C0034069 (UMLS CUI [3,1])
C0205231 (UMLS CUI [3,2])
C0231220 (UMLS CUI [3,3])
C1868885 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0742758 (UMLS CUI [6,1])
C1275491 (UMLS CUI [6,2])
C0003811 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C0421258 (UMLS CUI [8])
C0009450 (UMLS CUI [9])
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