Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: OGX-011 (Drug); buserelin (Drug); flutamide (Drug); conventional surgery (Procedure); neoadjuvant therapy (Procedure)
Phase: Phase 1
Status: Completed
Sponsored by: National Cancer Institute of Canada Official(s) and/or principal investigator(s):
Kim N. Chi, MD, Study Chair, Affiliation: British Columbia Cancer Agency
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.
Clinical Details
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 design: Treatment, Open Label
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
British Columbia Cancer Agency - Vancouver Cancer Centre, Vancouver, British Columbia V5Z 4E6, Canada
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 2002
Last updated: May 23, 2008
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