Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: buserelin Drug: custirsen sodium Drug: flutamide Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
| Study Start Date: | December 2002 |
| Study Completion Date: | September 2008 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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| Canada, British Columbia | |
| British Columbia Cancer Agency - Vancouver Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Study Chair: | Kim N. Chi, MD | British Columbia Cancer Agency |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00054106 History of Changes |
| Other Study ID Numbers: | I153, CAN-NCIC-IND153, ONCOGENEX-OGX-01-01, CDR0000269888 |
| Study First Received: | February 5, 2003 |
| Last Updated: | November 7, 2010 |
| Health Authority: | United States: Federal Government |
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 Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Buserelin Flutamide Hormones Fertility Agents, Female |
Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013