Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003236
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Women With Previously Treated Metastatic Breast Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Randomized Phase II Study of Human C-raf Kinase Antisense Oligonucleotide Isis 5132 CGP 69846A or Human Pkc-Alpha Antisence Oligonucleotide ISIS 3521 CGP 64128A in Women With Previously Treated Matastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 Randomized phase II trial to compare the effectiveness of ISIS 5132 with ISIS 3521 in treating women who have metastatic breast cancer that has not responded to previous therapy
PURPOSE Randomized phase II trial to compare the effectiveness of ISIS 5132 with ISIS 3521 in treating women who have metastatic breast cancer that has not responded to previous therapy
Detailed Description:
OBJECTIVES I Estimate the proportion of women with previously treated metastatic breast cancer who are progression free at 4 months after receiving ISIS 5132 or ISIS 3521 II Determine duration of response to these treatment regimens in this patient population III Evaluate toxicities and tolerability of these treatment regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to number of prior therapies for metastatic breast cancer 1 vs 2 Patients are randomized to one of two treatment arms Arm I closed 122299 Arm I Patients receive ISIS 5132 IV continuously over 21 days closed 122299 Arm II Patients receive ISIS 3521 IV continuously over 21 days Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity After every 2 courses patients are evaluated for response Patients are followed every 3 months for the first 2 years every 6 months the next 3 years then annually thereafter
PROJECTED ACCRUAL A maximum of 68 patients 34 per arm will be accrued in this study Arm I closed 122299
OUTLINE This is a randomized multicenter study Patients are stratified according to number of prior therapies for metastatic breast cancer 1 vs 2 Patients are randomized to one of two treatment arms Arm I closed 122299 Arm I Patients receive ISIS 5132 IV continuously over 21 days closed 122299 Arm II Patients receive ISIS 3521 IV continuously over 21 days Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity After every 2 courses patients are evaluated for response Patients are followed every 3 months for the first 2 years every 6 months the next 3 years then annually thereafter
PROJECTED ACCRUAL A maximum of 68 patients 34 per arm will be accrued in this study Arm I closed 122299
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| ECOG-3197 | None | None | None |