ID

21542

Descripción

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

Palabras clave

Versiones (1)
  1. 26/4/17 26/4/17 -
Subido en

26 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00286793

Inglés

Eligibility Prostate Cancer NCT00286793

1 formularios  
Inclusion Criteria
Descripción

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.
Descripción

PSA Level

Tipo de datos

boolean

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

Metastatic disease

Tipo de datos

boolean

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

ECOG Performance Status

Tipo de datos

boolean

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

Hematologic function

Tipo de datos

boolean

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

Liver and renal function

Tipo de datos

boolean

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

Swallow ability and retain oral medication

Tipo de datos

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.
Descripción

Disease progression during treatment with docetaxel regimen

Tipo de datos

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.
Descripción

Docetaxel dosage

Tipo de datos

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.
Descripción

Prior pharmacotherapy and radiation

Tipo de datos

boolean

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

Exclusion Criteria

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

Chemotherapy for HRPC

Tipo de datos

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.
Descripción

CNS metastases

Tipo de datos

boolean

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

Secondary or prior malignancy

Tipo de datos

boolean

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

Prior Radiation to bone marrow

Tipo de datos

boolean

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

Peripheral neuropathy grade

Tipo de datos

boolean

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

Comorbidity

Tipo de datos

boolean

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

Recovery from surgical procedures

Tipo de datos

boolean

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

Concurrent antineoplastic therapy

Tipo de datos

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)
Descripción

Concurrent anti-androgen hormonal therapy

Tipo de datos

boolean

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

Eligibility Prostate Cancer NCT00286793

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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