ID

21542

Description

Safety and Efficacy Study of AT-101 in Combination With Docetaxel and Prednisone in Men With HRPC; ODM derived from: https://clinicaltrials.gov/show/NCT00286793

Link

https://clinicaltrials.gov/show/NCT00286793

Keywords

Versions (1)
  1. 4/26/17 4/26/17 -
Uploaded on

April 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00286793

English

Eligibility Prostate Cancer NCT00286793

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. rising prostate specific antigen (psa) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (lhrh) agonist therapy.
Description

PSA Level

Data type

boolean

Alias
UMLS CUI [1]
C0201544
2. patients must have metastatic disease by bone scan, computed tomography (ct) scan, or magnetic resonance imaging (mri).
Description

Metastatic disease

Data type

boolean

Alias
UMLS CUI [1]
C0027627
3. ecog performance status 0 or 1
Description

ECOG Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
4. adequate hematologic function
Description

Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
5. adequate liver and renal function
Description

Liver and renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
6. able to swallow and retain oral medication.
Description

Swallow ability and retain oral medication

Data type

boolean

Alias
UMLS CUI [1]
C0566355
UMLS CUI [2,1]
C0566321
UMLS CUI [2,2]
C0175795
7. patients enrolled into cohort b must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising psa, progression of disease per recist, or >2 new lesions on bone scan.
Description

Disease progression during treatment with docetaxel regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0246415
8. patients enrolled into cohort b must have received at least two cycles of docetaxel. minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule.
Description

Docetaxel dosage

Data type

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0178602
9. at least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.
Description

Prior pharmacotherapy and radiation

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0279134
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients enrolled into cohort a must not have received prior chemotherapy for hrpc.
Description

Chemotherapy for HRPC

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1328504
2. known history of or clinical evidence of central nervous system (cns) metastases.
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
3. active secondary malignancy or history of other malignancy within the last 5 years.
Description

Secondary or prior malignancy

Data type

boolean

Alias
UMLS CUI [1]
C3266877
UMLS CUI [2]
C2735088
4. prior history of radiation therapy to > 25% of the bone marrow
Description

Prior Radiation to bone marrow

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
5. peripheral neuropathy of > grade 2
Description

Peripheral neuropathy grade

Data type

boolean

Alias
UMLS CUI [1]
C3869673
6. uncontrolled concurrent illness
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
7. failure to recover fully, as judged by the investigator, from prior surgical procedures.
Description

Recovery from surgical procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0237820
UMLS CUI [1,2]
C0543467
8. concurrent anti-cancer therapy other than docetaxel and prednisone.
Description

Concurrent antineoplastic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C2346834
UMLS CUI [1,2]
C0009429
9. patients must not be receiving concurrent anti-androgen hormonal therapy for hrpc (lhrh therapies are acceptable to maintain castrate levels of testosterone)
Description

Concurrent anti-androgen hormonal therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0009429
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Similar models

Eligibility Prostate Cancer NCT00286793

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
PSA Level
Item
1. rising prostate specific antigen (psa) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (lhrh) agonist therapy.
boolean
C0201544 (UMLS CUI [1])
Metastatic disease
Item
2. patients must have metastatic disease by bone scan, computed tomography (ct) scan, or magnetic resonance imaging (mri).
boolean
C0027627 (UMLS CUI [1])
ECOG Performance Status
Item
3. ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function
Item
4. adequate hematologic function
boolean
C0221130 (UMLS CUI [1])
Liver and renal function
Item
5. adequate liver and renal function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
Swallow ability and retain oral medication
Item
6. able to swallow and retain oral medication.
boolean
C0566355 (UMLS CUI [1])
C0566321 (UMLS CUI [2,1])
C0175795 (UMLS CUI [2,2])
Disease progression during treatment with docetaxel regimen
Item
7. patients enrolled into cohort b must have documented progression of disease during treatment with a docetaxel-containing regimen by meeting one or more of the following criteria- rising psa, progression of disease per recist, or >2 new lesions on bone scan.
boolean
C0242656 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
Docetaxel dosage
Item
8. patients enrolled into cohort b must have received at least two cycles of docetaxel. minimum doses of prior docetaxel permitted are 60 mg/m2 on a q 3 week schedule or 20 mg/m2 on a weekly schedule.
boolean
C0246415 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Prior pharmacotherapy and radiation
Item
9. at least 4 weeks since prior flutamide, megestrol, ketoconazole, and radiotherapy, and at least 6 weeks since prior bicalutamide or nilutamide.
boolean
C0013216 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy for HRPC
Item
1. patients enrolled into cohort a must not have received prior chemotherapy for hrpc.
boolean
C0392920 (UMLS CUI [1,1])
C1328504 (UMLS CUI [1,2])
CNS metastases
Item
2. known history of or clinical evidence of central nervous system (cns) metastases.
boolean
C0686377 (UMLS CUI [1])
Secondary or prior malignancy
Item
3. active secondary malignancy or history of other malignancy within the last 5 years.
boolean
C3266877 (UMLS CUI [1])
C2735088 (UMLS CUI [2])
Prior Radiation to bone marrow
Item
4. prior history of radiation therapy to > 25% of the bone marrow
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
Peripheral neuropathy grade
Item
5. peripheral neuropathy of > grade 2
boolean
C3869673 (UMLS CUI [1])
Comorbidity
Item
6. uncontrolled concurrent illness
boolean
C0009488 (UMLS CUI [1])
Recovery from surgical procedures
Item
7. failure to recover fully, as judged by the investigator, from prior surgical procedures.
boolean
C0237820 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Concurrent antineoplastic therapy
Item
8. concurrent anti-cancer therapy other than docetaxel and prednisone.
boolean
C2346834 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
Concurrent anti-androgen hormonal therapy
Item
9. patients must not be receiving concurrent anti-androgen hormonal therapy for hrpc (lhrh therapies are acceptable to maintain castrate levels of testosterone)
boolean
C0279492 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
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