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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00054106 |
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Date of registration:
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05/02/2003 |
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Primary sponsor: |
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Public title:
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Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
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Scientific title:
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A Phase I Study Of Combination Neoadjuvant Hormone Therapy And Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior To Radical Prostatectomy In Patients With Localized Prostate Cancer |
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Date of first enrolment:
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December 2002 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00054106 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Kim N. Chi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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British Columbia Cancer Agency |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- High-risk, localized disease that is previously untreated
- Minimum of 2 positive biopsies
- Meets at least 1 of the following criteria:
- Stage T3
- Serum PSA greater than 10 ng/mL
- Gleason score 7-10
- Gleason score 6 and at least 3 positive biopsies
- Potential candidate for radical prostatectomy
PATIENT CHARACTERISTICS:
Age
- Over 18
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10.0 g/dL
Hepatic
- Bilirubin normal
- AST and ALT normal
- PTT normal
- INR normal
Renal
- Creatinine normal
Cardiovascular
- No significant cardiac dysfunction
Other
- Fertile patients must use effective contraception
- No known hypersensitivity to oligonucleotides, luteinizing hormone-releasing hormone
analogs, or anti-androgens
- No evidence of active uncontrolled infection
- No other malignancy within the past 5 years except adequately treated nonmelanoma
skin cancer
- No other serious illness, psychiatric disorder, or medical condition that would
preclude study compliance
- No history of a significant neurological disorder that would preclude informed
consent
- No geographical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for prostate cancer
Endocrine therapy
- No prior hormonal therapy for prostate cancer
Radiotherapy
- No prior radiotherapy for prostate cancer
- No concurrent radiotherapy
Surgery
- Not specified
Other
- No concurrent heparin or warfarin anticoagulation
- No other concurrent investigational therapy
- No other concurrent cytotoxic therapy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: buserelin
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Drug: custirsen sodium
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Drug: flutamide
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Procedure: conventional surgery
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Procedure: neoadjuvant therapy
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Secondary ID(s)
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CAN-NCIC-IND153
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CDR0000269888
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I153
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ONCOGENEX-OGX-01-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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