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

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00054106

Collaborator

(none)

Enrollment

Location

69.6

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: buserelin Drug: custirsen sodium Drug: flutamide Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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

Actual Study Start Date :

Dec 6, 2002

Actual Primary Completion Date :

Sep 23, 2004

Actual Study Completion Date :

Sep 22, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	British Columbia Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6

Sponsors and Collaborators

NCIC Clinical Trials Group

Investigators

Study Chair: Kim N. Chi, MD, British Columbia Cancer Agency

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NCIC Clinical Trials Group

ClinicalTrials.gov Identifier:

NCT00054106

Other Study ID Numbers:

I153
CAN-NCIC-IND153
ONCOGENEX-OGX-01-01
CDR0000269888

First Posted:

Feb 6, 2003

Last Update Posted:

Apr 8, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by NCIC Clinical Trials Group

adenocarcinoma of the prostate

stage III prostate cancer

stage II prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms

Flutamide

Buserelin

Study Results

No Results Posted as of Apr 8, 2020