Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258388
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2005-11-22
Brief Title:
Docetaxel and Prednisone WithOut OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Phase II Study of OGX-011 in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Hormone Refractory 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 Drugs used in chemotherapy such as docetaxel and prednisone 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 and prednisone kill more tumor cells by making tumor cells less resistant to the drugs
PURPOSE This randomized phase II trial is studying how well giving docetaxel and prednisone with or without OGX-011 works in treating patients with recurrent or metastatic prostate cancer that did not respond to previous hormone therapy
PURPOSE This randomized phase II trial is studying how well giving docetaxel and prednisone with or without OGX-011 works in treating patients with recurrent or metastatic prostate cancer that did not respond to previous hormone therapy
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy in terms of prostate-specific antigen response of docetaxel and prednisone with or without OGX-011 in patients with hormone-refractory locally recurrent or metastatic prostate cancer
Secondary
Determine the objective response rate and duration in patients treated with these regimens
Determine the safety and toxic effects of these regimens in these patients
Determine the overall and progression-free survival of patients treated with these regimens
OUTLINE This is a multicenter randomized open-label study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive a loading dose of OGX-011 IV over 2 hours on days -7 -5 and -3 Patients then receive OGX-011 IV over 2 hours on days 1 8 and 15 docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21 Treatment repeats every 3 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21 Treatment repeats every 3 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
Primary
Determine the efficacy in terms of prostate-specific antigen response of docetaxel and prednisone with or without OGX-011 in patients with hormone-refractory locally recurrent or metastatic prostate cancer
Secondary
Determine the objective response rate and duration in patients treated with these regimens
Determine the safety and toxic effects of these regimens in these patients
Determine the overall and progression-free survival of patients treated with these regimens
OUTLINE This is a multicenter randomized open-label study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive a loading dose of OGX-011 IV over 2 hours on days -7 -5 and -3 Patients then receive OGX-011 IV over 2 hours on days 1 8 and 15 docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21 Treatment repeats every 3 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21 Treatment repeats every 3 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000450846 | OTHER | PDQ | None |
| CAN-NCIC-IND165 | OTHER | None | None |
| ONCOGENEX-OGX-011-03 | OTHER | None | None |
| FHCRC-6084 | OTHER | None | None |
| UWCC-UW-6084 | OTHER | None | None |
| UWCC-06-0499-HD | OTHER | None | None |