Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003892
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
1999-11-01
Brief Title:
ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
Phase II Study of CGP 69846A ISIS 5132 in Recurrent Epithelial Ovarian 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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of ISIS 5132 in treating patients who have metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy
PURPOSE Phase II trial to study the effectiveness of ISIS 5132 in treating patients who have metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES I Determine the efficacy of ISIS 5132 by evaluating objective response and duration of response in patients with recurrent ovarian epithelial cancer II Determine the tolerability and quantitative toxicity of ISIS 5132 in this patient population
OUTLINE This is a multicenter study Patients receive ISIS 5132 IV continuously for 21 days Courses are repeated every 28 days Treatment continues for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity Patients with documented complete response receive an additional 2 courses Patients with documented partial response receive an additional 4 courses Patients are followed at 4 weeks then every 3 months until disease relapse or progression
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study over 12-15 months
OUTLINE This is a multicenter study Patients receive ISIS 5132 IV continuously for 21 days Courses are repeated every 28 days Treatment continues for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity Patients with documented complete response receive an additional 2 courses Patients with documented partial response receive an additional 4 courses Patients are followed at 4 weeks then every 3 months until disease relapse or progression
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study over 12-15 months
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 |
|---|---|---|---|
| CDR0000067061 | OTHER | PDQ | None |
| CAN-NCIC-IND116 | OTHER | None | None |