Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	Over 18	Other, Pharmaceutical / Industry	CAN-NCIC-IND153 ONCOGENEX-OGX-01-01, NCT00054106, IND153

Objectives

1. 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.
2. Determine the toxicity of this regimen in these patients.
3. Determine the pharmacokinetics of OGX-011 when this regimen is administered in these patients..
4. Assess the effects of this regimen on pathologic complete response rates in these patients.
5. Correlate plasma and/or prostate concentrations of OGX-011 with patient response or toxicity measures.

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

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

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

Approximately 25-33 patients will be accrued for this study.

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.

Chi KN, Eisenhauer E, Fazli L, et al.: A phase I pharmacokinetic and pharmacodynamic study of OGX-011, a 2'-methoxyethyl antisense oligonucleotide to clusterin, in patients with localized prostate cancer. J Natl Cancer Inst 97 (17): 1287-96, 2005.[PUBMED Abstract]

Chi KN, Eisenhauer E, Fazli L, et al.: A phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of OGX-011, a 2’methoxyethyl phosphorothioate antisense to clusterin, in patients with prostate cancer prior to radical prostatectomy. [Abstract] J Clin Oncol 22 (Suppl 14): A-3033, 203s, 2004.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Kim Chi, MD, Protocol chair		Ph: 604-877-6000 ext. 2746; 800-663-3333 Email: kchi@bccancer.bc.ca

Registry Information
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
Trial Start Date		2002-12-06
Registered in ClinicalTrials.gov		NCT00054106
Date Submitted to PDQ		2002-12-18
Information Last Verified		2005-08-08

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