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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
buserelin
custirsen sodium
flutamide
conventional surgery
neoadjuvant therapy
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage III prostate cancer, stage II prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • British Columbia Cancer Agency - Vancouver Cancer Centre

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
August 3, 2023
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00054106
Brief Title
Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2002 (Actual)
Primary Completion Date
September 23, 2004 (Actual)
Study Completion Date
September 22, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage III prostate cancer, stage II prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
buserelin
Intervention Type
Drug
Intervention Name(s)
custirsen sodium
Intervention Type
Drug
Intervention Name(s)
flutamide
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim N. Chi, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Study Chair
Facility Information:
Facility Name
British Columbia Cancer Agency - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16145049
Citation
Chi KN, Eisenhauer E, Fazli L, Jones EC, Goldenberg SL, Powers J, Tu D, Gleave ME. 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. 2005 Sep 7;97(17):1287-96. doi: 10.1093/jnci/dji252.
Results Reference
result
Citation
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.
Results Reference
result

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

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