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
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Kim N. Chi, MD
Study Chair
British Columbia Cancer Agency
United States: Federal Government
I153
NCT00054106
December 2002
September 2008
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