Finding studies
Finding studies
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Lead
NCIC Clinical Trials Group
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.
Age
18–120
Sex
MALE
Healthy volunteers
Not accepted