ID

18978

Description

Study of Irofulven in Patients With Hormone-refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00124566

Link

https://clinicaltrials.gov/show/NCT00124566

Keywords

Versions (1)
  1. 11/28/16 11/28/16 -
Uploaded on

November 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00124566

English

Eligibility Prostate Cancer NCT00124566

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
to be included in the study, patients must meet the following criteria:
Description

criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. cancer of the prostate confirmed by a biopsy sample.
Description

Prostate carcinoma Biopsy sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0677862
2. 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. disease must have spread beyond the prostate as proven by chest x ray, abdominal and pelvic computed tomography (ct) scan, bone scan or clinical examination.
Description

Neoplasm Metastasis | Plain chest X-ray | CT of abdomen | Computed Tomography (CT) of Pelvis | scan of bone | examination; clinical

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C0039985
UMLS CUI [3]
C0412620
UMLS CUI [4]
C0412628
UMLS CUI [5]
C0203668
UMLS CUI [6]
C1456356
4. at least one prior hormonal treatment with documented disease progression during hormone therapy.
Description

Hormone Therapy | Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0242656
5. one previous line of chemotherapy that included taxotere® (as monotherapy or in combination). this could be in addition to estramustine single agent therapy.
Description

Taxotere | Chemotherapy | Combined Modality Therapy | Estramustine

Data type

boolean

Alias
UMLS CUI [1]
C0699967
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0014921
6. disease progression during prior taxotere-based therapy or within 3 months of discontinuing.
Description

Taxotere | Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C0699967
UMLS CUI [2]
C0242656
7. recovered from any toxic effects of prior chemotherapy, radiotherapy and surgery.
Description

Toxic effect Chemotherapy Related | Toxic effect Therapeutic radiology procedure Related | Toxic effect Operative Surgical Procedure Related | Patient Recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0521108
8. recovered from any toxic effects associated with other investigational drugs, if applicable.
Description

Toxic effect Investigational New Drugs Related | Patient Recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0521108
9. signed informed consent obtained prior to initiation of any study-specific procedures or treatment.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients cannot participate in the study if any of the following apply:
Description

Study Subject Participation Status | criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
1. unable to use prednisone.
Description

Prednisone Use Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C1299582
2. prior treatment with irofulven, capecitabine (xeloda), continuous/protracted infusion 5-fu (5-fluorouracil) (infusion duration greater than or equal to 24 hours), other fluoropyrimidines or mitoxantrone.
Description

irofulven | capecitabine | Xeloda | Fluorouracil Infusion Duration | fluoropyrimidine | Mitoxantrone

Data type

boolean

Alias
UMLS CUI [1]
C0532362
UMLS CUI [2]
C0671970
UMLS CUI [3]
C0724419
UMLS CUI [4,1]
C0016360
UMLS CUI [4,2]
C0574032
UMLS CUI [4,3]
C0449238
UMLS CUI [5]
C0596581
UMLS CUI [6]
C0026259
3. ongoing treatment with a corticosteroid at a prednisone-equivalent dose > 10 mg/day.
Description

Steroid therapy Dose Prednisone Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0032952
UMLS CUI [1,4]
C0205163
4. more than 1 prior treatment with either 153sm or 89sr, or radioisotope treatment within 8 weeks prior to entering this study.
Description

Sm153 | Strontium-89 | Radionuclide therapy

Data type

boolean

Alias
UMLS CUI [1]
C0677942
UMLS CUI [2]
C0281385
UMLS CUI [3]
C0203608
5. initiation of treatment with bisphosphonate agents (e.g., pamidronate, etidronate) within 2 months of entering the study. pre-existing treatment with bisphosphonate agents is to be continued during this study.
Description

Diphosphonates | pamidronate | Etidronate

Data type

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C0043603
UMLS CUI [3]
C0086268
6. treatment with warfarin and/or phenytoin within 14 days before entering this study or during the study period.
Description

Warfarin | Phenytoin

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0031507
please note: there are additional inclusion/exclusion criteria. the study center will determine if patients meet all of the criteria. if patients do not qualify for the trial, study personnel will explain the reasons. if patients do qualify, study personnel will explain the trial in detail and answer any questions. patients can then decide if they wish to participate.
Description

Clinical Trial Eligibility Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Prostate Cancer NCT00124566

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
criteria Fulfill
Item
to be included in the study, patients must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Prostate carcinoma Biopsy sample
Item
1. cancer of the prostate confirmed by a biopsy sample.
boolean
C0600139 (UMLS CUI [1,1])
C0677862 (UMLS CUI [1,2])
Age
Item
2. 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Neoplasm Metastasis | Plain chest X-ray | CT of abdomen | Computed Tomography (CT) of Pelvis | scan of bone | examination; clinical
Item
3. disease must have spread beyond the prostate as proven by chest x ray, abdominal and pelvic computed tomography (ct) scan, bone scan or clinical examination.
boolean
C0027627 (UMLS CUI [1])
C0039985 (UMLS CUI [2])
C0412620 (UMLS CUI [3])
C0412628 (UMLS CUI [4])
C0203668 (UMLS CUI [5])
C1456356 (UMLS CUI [6])
Hormone Therapy | Disease Progression
Item
4. at least one prior hormonal treatment with documented disease progression during hormone therapy.
boolean
C0279025 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Taxotere | Chemotherapy | Combined Modality Therapy | Estramustine
Item
5. one previous line of chemotherapy that included taxotere® (as monotherapy or in combination). this could be in addition to estramustine single agent therapy.
boolean
C0699967 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0014921 (UMLS CUI [4])
Taxotere | Disease Progression
Item
6. disease progression during prior taxotere-based therapy or within 3 months of discontinuing.
boolean
C0699967 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Toxic effect Chemotherapy Related | Toxic effect Therapeutic radiology procedure Related | Toxic effect Operative Surgical Procedure Related | Patient Recovered
Item
7. recovered from any toxic effects of prior chemotherapy, radiotherapy and surgery.
boolean
C0600688 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C0521108 (UMLS CUI [4,2])
Toxic effect Investigational New Drugs Related | Patient Recovered
Item
8. recovered from any toxic effects associated with other investigational drugs, if applicable.
boolean
C0600688 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
Informed Consent
Item
9. signed informed consent obtained prior to initiation of any study-specific procedures or treatment.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | criteria Fulfill
Item
patients cannot participate in the study if any of the following apply:
boolean
C2348568 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Prednisone Use Unable
Item
1. unable to use prednisone.
boolean
C0032952 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
irofulven | capecitabine | Xeloda | Fluorouracil Infusion Duration | fluoropyrimidine | Mitoxantrone
Item
2. prior treatment with irofulven, capecitabine (xeloda), continuous/protracted infusion 5-fu (5-fluorouracil) (infusion duration greater than or equal to 24 hours), other fluoropyrimidines or mitoxantrone.
boolean
C0532362 (UMLS CUI [1])
C0671970 (UMLS CUI [2])
C0724419 (UMLS CUI [3])
C0016360 (UMLS CUI [4,1])
C0574032 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
C0596581 (UMLS CUI [5])
C0026259 (UMLS CUI [6])
Steroid therapy Dose Prednisone Equivalent
Item
3. ongoing treatment with a corticosteroid at a prednisone-equivalent dose > 10 mg/day.
boolean
C0149783 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0032952 (UMLS CUI [1,3])
C0205163 (UMLS CUI [1,4])
Sm153 | Strontium-89 | Radionuclide therapy
Item
4. more than 1 prior treatment with either 153sm or 89sr, or radioisotope treatment within 8 weeks prior to entering this study.
boolean
C0677942 (UMLS CUI [1])
C0281385 (UMLS CUI [2])
C0203608 (UMLS CUI [3])
Diphosphonates | pamidronate | Etidronate
Item
5. initiation of treatment with bisphosphonate agents (e.g., pamidronate, etidronate) within 2 months of entering the study. pre-existing treatment with bisphosphonate agents is to be continued during this study.
boolean
C0012544 (UMLS CUI [1])
C0043603 (UMLS CUI [2])
C0086268 (UMLS CUI [3])
Warfarin | Phenytoin
Item
6. treatment with warfarin and/or phenytoin within 14 days before entering this study or during the study period.
boolean
C0043031 (UMLS CUI [1])
C0031507 (UMLS CUI [2])
Clinical Trial Eligibility Criteria Additional
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if patients meet all of the criteria. if patients do not qualify for the trial, study personnel will explain the reasons. if patients do qualify, study personnel will explain the trial in detail and answer any questions. patients can then decide if they wish to participate.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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