Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

NCIC-Clinical Trials Group

Kim N. Chi

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00054106
Information obtained from ClinicalTrials.gov on December 14, 2011

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