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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


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Kim N. Chi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

United States: Federal Government

Study ID:

I153

NCT ID:

NCT00054106

Start Date:

December 2002

Completion Date:

September 2008

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage III prostate cancer
  • stage II prostate cancer
  • Prostatic Neoplasms

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