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Home > "H" Clinical Trials Conditions > Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer  Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
For Condition: stage 3 prostate cancer,adenocarcinoma of the prostate,stage 2 prostate cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as flutamide and buserelin may stop the adrenal glands from producing androgens. OGX-011 may help flutamide and buserelin kill more tumor cells by making tumor cells more sensitive to the drugs. Giving flutamide and buserelin with OGX-011 before surgery may shrink the tumor so it can be removed during surgery. PURPOSE: Phase I trial to study the effectiveness of combining hormone therapy with OGX-011 before radical prostatectomy in treating patients who have prostate cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose and recommended phase II dose of OGX-011 (clusterin antisense oligonucleotide) when administered with neoadjuvant hormonal therapy before radical prostatectomy in patients with adenocarcinoma of the prostate. - Determine the toxicity of this regimen in these patients. - Determine the pharmacokinetics of OGX-011 when this regimen is administered in these patients.. - Assess the effects of this regimen on pathologic complete response rates in these patients. - Correlate plasma and/or prostate concentrations of OGX-011 with patient response or toxicity measures. OUTLINE: This is a dose-escalation study of OGX-011. Patients receive OGX-011 IV over 2 hours on days 1, 3, 5, 8, 15, 22, and 29; oral flutamide three times daily for 4 weeks; and buserelin subcutaneously on day 1. Cohorts of 3-6 patients (except for 1 patient at starting dose) receive escalating doses of OGX-011 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose is the dose preceding the MTD. Patients undergo radical prostatectomy and bilateral pelvic lymphadenectomy 1 week after the last dose of neoadjuvant therapy. Patients are followed at 7 days after surgery and then at 3 months. PROJECTED ACCRUAL: Approximately 25-33 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KimChi, Study Chair, British Columbia Cancer Agency
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Kim Chi 604-877-6000 Ext. 2746
Additional Information:
Study ID Numbers: CDR0000269888; ONCOGENEX-OGX-01-01,CAN-NCIC-IND153
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054106
Other Adenocarcinoma Of The Prostate Studies:
1. Diet and PSA Levels in Patients With Prostate Cancer
2. Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
3. Radiation Therapy in Treating Patients With Prostate Cancer
4. Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer
5. Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other British Columbia Clinical Trials
Other Vancouver Clinical Trials
Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
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