Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054106
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2003-02-05
Brief Title:
Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-IND153 | OTHER | None | None |
| CDR0000269888 | OTHER | PDQ | None |
| ONCOGENEX-OGX-01-01 | OTHER | None | None |