ID

42836

Descrizione

Intermittent Chemotherapy With or Without GM-CSF for Metastatic HPRC; ODM derived from: https://clinicaltrials.gov/show/NCT00488982

collegamento

https://clinicaltrials.gov/show/NCT00488982

Keywords

versioni (2)
  1. 24/08/17 24/08/17 -
  2. 17/09/21 17/09/21 -
Caricato su

17 settembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00488982

Inglese

Eligibility Prostate Cancer NCT00488982

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age over 18 years
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically documented adenocarcinoma of the prostate
Descrizione

Adenocarcinoma of prostate

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007112
3. progressive metastatic prostate cancer
Descrizione

Secondary malignant neoplasm of prostate Progressive

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0347001
UMLS CUI [1,2]
C0205329
4. castrate levels of testosterone (<50 ng/ml) must be maintained
Descrizione

Testosterone Castration Level Maintenance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0039601
UMLS CUI [1,2]
C0007347
UMLS CUI [1,3]
C0441889
UMLS CUI [1,4]
C0024501
5. prior hormonal therapy or medications :
Descrizione

Hormone Therapy | Hormone preparation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0019932
patients who are receiving an anti-androgen, secondary hormonal therapy (i.e. ketoconazole, aminoglutethimide, megestrol acetate, diethylstilbestrol), 5-alpha reductase inhibitor (i.e. finasteride (proscar), dutasteride (avodart)) or herbal prostate medication (i.e. saw palmetto, pc-spes, pc-plus) must discontinue the drug by the date of initiation of chemotherapy on study
Descrizione

Antiandrogen therapy | Hormone Therapy Secondary | Ketoconazole | Aminoglutethimide | Megestrol Acetate | Diethylstilbestrol | 5-alpha Reductase Inhibitors | Finasteride | Proscar | Dutasteride | Avodart | Plant Preparations Prostate | Saw palmetto | PC-SPES | Pharmaceutical Preparations To be stopped

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0175668
UMLS CUI [3]
C0022625
UMLS CUI [4]
C0002555
UMLS CUI [5]
C0065879
UMLS CUI [6]
C0012203
UMLS CUI [7]
C2936788
UMLS CUI [8]
C0060389
UMLS CUI [9]
C0678149
UMLS CUI [10]
C0754659
UMLS CUI [11]
C1170079
UMLS CUI [12,1]
C0949854
UMLS CUI [12,2]
C0033572
UMLS CUI [13]
C0771607
UMLS CUI [14]
C0756934
UMLS CUI [15,1]
C0013227
UMLS CUI [15,2]
C1272691
6. ≥ 4 weeks since major surgery and fully recovered
Descrizione

Major surgery | Fully recovered

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C2826210
7. ≥ 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to ≤grade 1
Descrizione

Toxicity Due to Therapeutic radiology procedure | Patient condition resolved Toxicity Grade

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1522449
UMLS CUI [2,1]
C0438113
UMLS CUI [2,2]
C2826262
8. ≥ 8 weeks since the last dose of strontium or samarium
Descrizione

Strontium | Samarium

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038467
UMLS CUI [2]
C0036147
9. sexually active patients must agree to use adequate contraception
Descrizione

Patients Sexually active Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
10. karnofsky performance status ≥ 60%
Descrizione

Karnofsky Performance Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0206065
11. life expectancy >12 weeks
Descrizione

Life Expectancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023671
12. required initial laboratory values absolute neutrophil count > 1500/ul platelets > 100,000/ul hemoglobin > 8.0 g/dl creatinine ≤ 2.0 x upper limit of normal bilirubin ≤upper limit of normal (uln)
Descrizione

Laboratory Results Initial Required | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Serum total bilirubin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0205265
UMLS CUI [1,3]
C1514873
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
UMLS CUI [5]
C0201976
UMLS CUI [6]
C1278039
ast/alt/alkaline phosphatase:
Descrizione

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201850
ast and alt and alkaline phosphatase must be within the range allowing for eligibility in determining eligibility, the more abnormal of the 2 values (ast or alt should be used. an abnormal alkaline phosphatase must be attributed to liver dysfunction and not metastatic bone involvement (i.e elevated ggtp or evidence of liver metastases)
Descrizione

AST level normal | Alanine aminotransferase normal | Serum alkaline phosphatase normal | Alkaline phosphatase abnormal Due to Liver Dysfunction | Involvement with Secondary malignant neoplasm of bone Absent | Gamma-glutamyl transferase raised | Secondary malignant neoplasm of liver

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0580474
UMLS CUI [2]
C0855620
UMLS CUI [3]
C0428334
UMLS CUI [4,1]
C0740888
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0086565
UMLS CUI [5,1]
C1314939
UMLS CUI [5,2]
C0153690
UMLS CUI [5,3]
C0332197
UMLS CUI [6]
C0151662
UMLS CUI [7]
C0494165
inclusion criteria for late enrolling patients:
Descrizione

Inclusion criteria Enrollment Late

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1516879
UMLS CUI [1,3]
C0205087
1. age over 18 years
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
2. histologically documented adenocarcinoma of the prostate
Descrizione

Adenocarcinoma of prostate

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007112
3. ≤3 cycles of prior docetaxel chemotherapy for metastatic disease permitted prior to enrollment
Descrizione

Docetaxel | Chemotherapy cycle Quantity Neoplasm Metastasis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0246415
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
4. docetaxel must have been administered on an every 3 week schedule
Descrizione

Docetaxel | Drug Administration Schedule Frequency

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0246415
UMLS CUI [2,1]
C0013154
UMLS CUI [2,2]
C0439603
5. each docetaxel dose must have been between 60 and 75 mg/m2
Descrizione

Docetaxel Dose

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0178602
6. castrate levels of testosterone <50 ng/ml
Descrizione

Testosterone Castration Level

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0039601
UMLS CUI [1,2]
C0007347
UMLS CUI [1,3]
C0441889
7. daily use of other steroids (hydrocortisone, dexamethasone) instead of prednisone or no steroids, is permitted up until time of enrollment
Descrizione

Steroids Daily | Hydrocortisone | Dexamethasone | Prednisone | Steroids Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0332173
UMLS CUI [2]
C0020268
UMLS CUI [3]
C0011777
UMLS CUI [4]
C0032952
UMLS CUI [5,1]
C0038317
UMLS CUI [5,2]
C0332197
8. a psa level must have been documented within 6 weeks of initiating docetaxel chemotherapy
Descrizione

PSA Level | Docetaxel

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4086720
UMLS CUI [2]
C0246415
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior systemic chemotherapy for prostate cancer, other than q 3-week docetaxel/prednisone. prior neoadjuvant or adjuvant chemotherapy is permitted if there was no evidence of disease relapse within 12 months of the last dose of chemotherapy.
Descrizione

Systemic Chemotherapy Prostate carcinoma | Exception Docetaxel | Exception Prednisone | Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant | Recurrent disease Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0600139
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0246415
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0032952
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0600558
UMLS CUI [5]
C0085533
UMLS CUI [6,1]
C0277556
UMLS CUI [6,2]
C0332197
2. >3 cycles of q3 week docetaxel/prednisone chemotherapy has already been administered to the patient
Descrizione

Docetaxel | Prednisone | Chemotherapy cycle Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0246415
UMLS CUI [2]
C0032952
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C1265611
3. peripheral neuropathy >grade 1
Descrizione

Peripheral Neuropathy CTCAE Grades

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
4. prior immunotherapy including systemic gm-csf or vaccines utilizing gm-csf; prior g-csf support of chemotherapy-related neutropenia is permitted
Descrizione

Immunotherapy | GM-CSF Systemic | Vaccines Using GM-CSF | G-CSF Support | Neutropenia Chemotherapy Related

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2,1]
C0079460
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0079460
UMLS CUI [4,1]
C0079459
UMLS CUI [4,2]
C1521721
UMLS CUI [5,1]
C0027947
UMLS CUI [5,2]
C0392920
UMLS CUI [5,3]
C0439849
5. prior biologic agents (i.e.,anti-angiogenic agents, anti-egfr inhibitors)≤ 4 weeks prior to registration
Descrizione

Biological agents | Angiogenesis Inhibitors | EGFR Antibody

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005515
UMLS CUI [2]
C0596087
UMLS CUI [3]
C4055105
6. more than two prior therapies with an investigational agent, completed ≤ 4 weeks prior to enrollment (no prior immunotherapeutics are allowed)
Descrizione

Investigational New Drugs Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1265611
7. myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (nyha class iii or higher) or uncontrolled cardiac arrhythmia
Descrizione

Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0742758
UMLS CUI [3,2]
C1275491
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205318
8. because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, hiv-positive patients receiving combination anti-retroviral therapy are excluded
Descrizione

HIV Seropositivity | Antiretroviral therapy Combined | Therapeutic Bone Marrow Suppression At risk Communicable Disease Lethal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C0205195
UMLS CUI [3,1]
C2698538
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0009450
UMLS CUI [3,4]
C3151529
9. patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 will be excluded
Descrizione

Severe allergy Docetaxel | Severe allergy Polysorbate 80 Drug Formulation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0032601
UMLS CUI [2,3]
C0524527
10. poorly controlled diabetes (fasting blood glucose >250) despite optimization of medical therapy
Descrizione

Diabetes mellitus poor control | Fasting blood glucose measurement | Therapeutic procedure Optimal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0860161
UMLS CUI [2]
C0428568
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2698651
exclusion criteria for late enrolling patients:
Descrizione

Exclusion Criteria Enrollment Late

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1516879
UMLS CUI [1,3]
C0205087
1. prior immunotherapy including systemic gm-csf or vaccines utilizing gm-csf; prior g-csf support for chemotherapy-related neutropenia is permitted
Descrizione

Immunotherapy | GM-CSF Systemic | Vaccines Using GM-CSF | G-CSF Support | Neutropenia Chemotherapy Related

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2,1]
C0079460
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0079460
UMLS CUI [4,1]
C0079459
UMLS CUI [4,2]
C1521721
UMLS CUI [5,1]
C0027947
UMLS CUI [5,2]
C0392920
UMLS CUI [5,3]
C0439849
2. delay of ≥6 weeks between any 2 chemotherapy cycles prior to enrollment on study
Descrizione

Chemotherapy cycle Quantity | Interval Delay

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1272706
UMLS CUI [2,2]
C0205421
3. cumulative delays ≥8 weeks between chemotherapy cycles prior to enrollment on study
Descrizione

Chemotherapy cycles | Interval Delay Cumulative

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1302181
UMLS CUI [2,1]
C1272706
UMLS CUI [2,2]
C0205421
UMLS CUI [2,3]
C1511559
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Similar models

Eligibility Prostate Cancer NCT00488982

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age over 18 years
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
2. histologically documented adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Secondary malignant neoplasm of prostate Progressive
Item
3. progressive metastatic prostate cancer
boolean
C0347001 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Testosterone Castration Level Maintenance
Item
4. castrate levels of testosterone (<50 ng/ml) must be maintained
boolean
C0039601 (UMLS CUI [1,1])
C0007347 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
C0024501 (UMLS CUI [1,4])
Hormone Therapy | Hormone preparation
Item
5. prior hormonal therapy or medications :
boolean
C0279025 (UMLS CUI [1])
C0019932 (UMLS CUI [2])
Antiandrogen therapy | Hormone Therapy Secondary | Ketoconazole | Aminoglutethimide | Megestrol Acetate | Diethylstilbestrol | 5-alpha Reductase Inhibitors | Finasteride | Proscar | Dutasteride | Avodart | Plant Preparations Prostate | Saw palmetto | PC-SPES | Pharmaceutical Preparations To be stopped
Item
patients who are receiving an anti-androgen, secondary hormonal therapy (i.e. ketoconazole, aminoglutethimide, megestrol acetate, diethylstilbestrol), 5-alpha reductase inhibitor (i.e. finasteride (proscar), dutasteride (avodart)) or herbal prostate medication (i.e. saw palmetto, pc-spes, pc-plus) must discontinue the drug by the date of initiation of chemotherapy on study
boolean
C0279492 (UMLS CUI [1])
C0279025 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0022625 (UMLS CUI [3])
C0002555 (UMLS CUI [4])
C0065879 (UMLS CUI [5])
C0012203 (UMLS CUI [6])
C2936788 (UMLS CUI [7])
C0060389 (UMLS CUI [8])
C0678149 (UMLS CUI [9])
C0754659 (UMLS CUI [10])
C1170079 (UMLS CUI [11])
C0949854 (UMLS CUI [12,1])
C0033572 (UMLS CUI [12,2])
C0771607 (UMLS CUI [13])
C0756934 (UMLS CUI [14])
C0013227 (UMLS CUI [15,1])
C1272691 (UMLS CUI [15,2])
Major surgery | Fully recovered
Item
6. ≥ 4 weeks since major surgery and fully recovered
boolean
C0679637 (UMLS CUI [1])
C2826210 (UMLS CUI [2])
Toxicity Due to Therapeutic radiology procedure | Patient condition resolved Toxicity Grade
Item
7. ≥ 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to ≤grade 1
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
C0438113 (UMLS CUI [2,1])
C2826262 (UMLS CUI [2,2])
Strontium | Samarium
Item
8. ≥ 8 weeks since the last dose of strontium or samarium
boolean
C0038467 (UMLS CUI [1])
C0036147 (UMLS CUI [2])
Patients Sexually active Contraceptive methods
Item
9. sexually active patients must agree to use adequate contraception
boolean
C0030705 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Karnofsky Performance Status
Item
10. karnofsky performance status ≥ 60%
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
11. life expectancy >12 weeks
boolean
C0023671 (UMLS CUI [1])
Laboratory Results Initial Required | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Serum total bilirubin measurement
Item
12. required initial laboratory values absolute neutrophil count > 1500/ul platelets > 100,000/ul hemoglobin > 8.0 g/dl creatinine ≤ 2.0 x upper limit of normal bilirubin ≤upper limit of normal (uln)
boolean
C1254595 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
ast/alt/alkaline phosphatase:
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201850 (UMLS CUI [3])
AST level normal | Alanine aminotransferase normal | Serum alkaline phosphatase normal | Alkaline phosphatase abnormal Due to Liver Dysfunction | Involvement with Secondary malignant neoplasm of bone Absent | Gamma-glutamyl transferase raised | Secondary malignant neoplasm of liver
Item
ast and alt and alkaline phosphatase must be within the range allowing for eligibility in determining eligibility, the more abnormal of the 2 values (ast or alt should be used. an abnormal alkaline phosphatase must be attributed to liver dysfunction and not metastatic bone involvement (i.e elevated ggtp or evidence of liver metastases)
boolean
C0580474 (UMLS CUI [1])
C0855620 (UMLS CUI [2])
C0428334 (UMLS CUI [3])
C0740888 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0086565 (UMLS CUI [4,3])
C1314939 (UMLS CUI [5,1])
C0153690 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0151662 (UMLS CUI [6])
C0494165 (UMLS CUI [7])
Inclusion criteria Enrollment Late
Item
inclusion criteria for late enrolling patients:
boolean
C1512693 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0205087 (UMLS CUI [1,3])
Age
Item
1. age over 18 years
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate
Item
2. histologically documented adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Docetaxel | Chemotherapy cycle Quantity Neoplasm Metastasis
Item
3. ≤3 cycles of prior docetaxel chemotherapy for metastatic disease permitted prior to enrollment
boolean
C0246415 (UMLS CUI [1])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
Docetaxel | Drug Administration Schedule Frequency
Item
4. docetaxel must have been administered on an every 3 week schedule
boolean
C0246415 (UMLS CUI [1])
C0013154 (UMLS CUI [2,1])
C0439603 (UMLS CUI [2,2])
Docetaxel Dose
Item
5. each docetaxel dose must have been between 60 and 75 mg/m2
boolean
C0246415 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Testosterone Castration Level
Item
6. castrate levels of testosterone <50 ng/ml
boolean
C0039601 (UMLS CUI [1,1])
C0007347 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
Steroids Daily | Hydrocortisone | Dexamethasone | Prednisone | Steroids Absent
Item
7. daily use of other steroids (hydrocortisone, dexamethasone) instead of prednisone or no steroids, is permitted up until time of enrollment
boolean
C0038317 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0020268 (UMLS CUI [2])
C0011777 (UMLS CUI [3])
C0032952 (UMLS CUI [4])
C0038317 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
PSA Level | Docetaxel
Item
8. a psa level must have been documented within 6 weeks of initiating docetaxel chemotherapy
boolean
C4086720 (UMLS CUI [1])
C0246415 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Systemic Chemotherapy Prostate carcinoma | Exception Docetaxel | Exception Prednisone | Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant | Recurrent disease Absent
Item
1. prior systemic chemotherapy for prostate cancer, other than q 3-week docetaxel/prednisone. prior neoadjuvant or adjuvant chemotherapy is permitted if there was no evidence of disease relapse within 12 months of the last dose of chemotherapy.
boolean
C1883256 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0032952 (UMLS CUI [3,2])
C0392920 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C0085533 (UMLS CUI [5])
C0277556 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Docetaxel | Prednisone | Chemotherapy cycle Quantity
Item
2. >3 cycles of q3 week docetaxel/prednisone chemotherapy has already been administered to the patient
boolean
C0246415 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
C1302181 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Peripheral Neuropathy CTCAE Grades
Item
3. peripheral neuropathy >grade 1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Immunotherapy | GM-CSF Systemic | Vaccines Using GM-CSF | G-CSF Support | Neutropenia Chemotherapy Related
Item
4. prior immunotherapy including systemic gm-csf or vaccines utilizing gm-csf; prior g-csf support of chemotherapy-related neutropenia is permitted
boolean
C0021083 (UMLS CUI [1])
C0079460 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0042210 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0079460 (UMLS CUI [3,3])
C0079459 (UMLS CUI [4,1])
C1521721 (UMLS CUI [4,2])
C0027947 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
Biological agents | Angiogenesis Inhibitors | EGFR Antibody
Item
5. prior biologic agents (i.e.,anti-angiogenic agents, anti-egfr inhibitors)≤ 4 weeks prior to registration
boolean
C0005515 (UMLS CUI [1])
C0596087 (UMLS CUI [2])
C4055105 (UMLS CUI [3])
Investigational New Drugs Quantity
Item
6. more than two prior therapies with an investigational agent, completed ≤ 4 weeks prior to enrollment (no prior immunotherapeutics are allowed)
boolean
C0013230 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable | Symptomatic congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Uncontrolled
Item
7. myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (nyha class iii or higher) or uncontrolled cardiac arrhythmia
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0742758 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
HIV Seropositivity | Antiretroviral therapy Combined | Therapeutic Bone Marrow Suppression At risk Communicable Disease Lethal
Item
8. because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, hiv-positive patients receiving combination anti-retroviral therapy are excluded
boolean
C0019699 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C2698538 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0009450 (UMLS CUI [3,3])
C3151529 (UMLS CUI [3,4])
Severe allergy Docetaxel | Severe allergy Polysorbate 80 Drug Formulation
Item
9. patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 will be excluded
boolean
C2945656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C0524527 (UMLS CUI [2,3])
Diabetes mellitus poor control | Fasting blood glucose measurement | Therapeutic procedure Optimal
Item
10. poorly controlled diabetes (fasting blood glucose >250) despite optimization of medical therapy
boolean
C0860161 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C2698651 (UMLS CUI [3,2])
Exclusion Criteria Enrollment Late
Item
exclusion criteria for late enrolling patients:
boolean
C0680251 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0205087 (UMLS CUI [1,3])
Immunotherapy | GM-CSF Systemic | Vaccines Using GM-CSF | G-CSF Support | Neutropenia Chemotherapy Related
Item
1. prior immunotherapy including systemic gm-csf or vaccines utilizing gm-csf; prior g-csf support for chemotherapy-related neutropenia is permitted
boolean
C0021083 (UMLS CUI [1])
C0079460 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0042210 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0079460 (UMLS CUI [3,3])
C0079459 (UMLS CUI [4,1])
C1521721 (UMLS CUI [4,2])
C0027947 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C0439849 (UMLS CUI [5,3])
Chemotherapy cycle Quantity | Interval Delay
Item
2. delay of ≥6 weeks between any 2 chemotherapy cycles prior to enrollment on study
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1272706 (UMLS CUI [2,1])
C0205421 (UMLS CUI [2,2])
Chemotherapy cycles | Interval Delay Cumulative
Item
3. cumulative delays ≥8 weeks between chemotherapy cycles prior to enrollment on study
boolean
C1302181 (UMLS CUI [1])
C1272706 (UMLS CUI [2,1])
C0205421 (UMLS CUI [2,2])
C1511559 (UMLS CUI [2,3])
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