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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00054106
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : August 4, 2023
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : December 10, 2002
Actual Primary Completion Date : September 23, 2004
Actual Study Completion Date : September 22, 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054106


Locations
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Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
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Study Chair: Kim N. Chi, MD British Columbia Cancer Agency
More Information
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Publications of Results:
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.

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Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00054106    
Other Study ID Numbers: I153
CAN-NCIC-IND153 ( Other Identifier: PDQ )
ONCOGENEX-OGX-01-01 ( Other Identifier: Oncogenex Technologies )
CDR0000269888 ( Other Identifier: PDQ )
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: August 4, 2023
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
adenocarcinoma of the prostate
stage III prostate cancer
stage II prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Flutamide
 Buserelin
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents