Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258375
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2005-11-22
Brief Title:
OGX-011 and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide OGX-011 in Combination With Docetaxel in Advanced Breast 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 Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing OGX-011 may help docetaxel kill more tumor cells by making tumor cells more sensitive to the drug
PURPOSE This phase II trial is studying how well giving OGX-011 together with docetaxel works in treating women with locally advanced or metastatic breast cancer
PURPOSE This phase II trial is studying how well giving OGX-011 together with docetaxel works in treating women with locally advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of OGX-011 and docetaxel in terms of objective tumor response rate in women with locally advanced or metastatic breast cancer
Secondary
Determine the tolerability and toxicity of this regimen in these patients
Determine the time to progression and overall survival of patients treated with this regimen
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive OGX-011 IV over 2 hours on days -7 -5 -3 1 8 and 15 of course 1 and on days 1 8 and 15 of all subsequent courses Patients also receive docetaxel IV over 1 hour on days 1 and 8 of all courses Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity
NOTE Course 1 is 28 days in length and all subsequent courses courses 2-10 are 21 days in length
After completion of study treatment patients are followed at 4 weeks and then periodically until disease progression
PROJECTED ACCRUAL Approximately 42 patients will be accrued for this study
Primary
Determine the efficacy of OGX-011 and docetaxel in terms of objective tumor response rate in women with locally advanced or metastatic breast cancer
Secondary
Determine the tolerability and toxicity of this regimen in these patients
Determine the time to progression and overall survival of patients treated with this regimen
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive OGX-011 IV over 2 hours on days -7 -5 -3 1 8 and 15 of course 1 and on days 1 8 and 15 of all subsequent courses Patients also receive docetaxel IV over 1 hour on days 1 and 8 of all courses Treatment repeats every 21 days for up to 10 courses in the absence of disease progression or unacceptable toxicity
NOTE Course 1 is 28 days in length and all subsequent courses courses 2-10 are 21 days in length
After completion of study treatment patients are followed at 4 weeks and then periodically until disease progression
PROJECTED ACCRUAL Approximately 42 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-IND164 | OTHER | None | None |
| ONCOGENEX-OGX-011-06 | OTHER | None | None |
| CDR0000450847 | OTHER | PDQ | None |