Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
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.
|Prostate Cancer||Drug: buserelin Drug: custirsen sodium Drug: flutamide Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 1|
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||December 2002|
|Study Completion Date:||September 2008|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054106
|Canada, British Columbia|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Study Chair:||Kim N. Chi, MD||British Columbia Cancer Agency|