Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258349
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2005-11-22
Brief Title:
Vorinostat and Trastuzumab in Treating Patients With Metastatic or Locally Recurrent Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Suberoylanilide Hydroxamic Acid SAHA in Combination With Trastuzumab Herceptin in Patients With Advanced Metastatic andor Local Chest Wall Recurrent Her-2 Amplified Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This phase III trial is studying the side effects and best dose of vorinostat when given together with trastuzumab and to see how well they work in treating patients with metastatic breast canceror breast cancer that has recurred in the chest wall Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as trastuzumab can block tumor growth in different ways Some find tumor cells and kill them or carry tumor-killing substances to them Others interfere with the ability of tumor cells to grow and spread Vorinostat and trastuzumab also may stop the growth of tumor cells by blocking blood flow to the tumor Giving vorinostat together with trastuzumab may be a better way to block tumor growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose of vorinostat in combination with trastuzumab Herceptin in patients with metastatic or local chest wall recurrent HER-2-amplified breast cancer Phase I II To determine the toxic effects of this regimen in these patients Phase I III To determine the response rate in patients treated with this regimen Phase II
SECONDARY OBJECTIVE
I To determine the time to progression in patients treated with this regimen Phase II
OUTLINE This is an open-label multicenter dose-escalation study of vorinostat
PHASE I Patients receive oral vorinostat twice daily on days 1-14 and trastuzumab Herceptin IV over 90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of vorinostat until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity At least 6 patients are treated at the MTD
PHASE II Patients receive vorinostat at the MTD and trastuzumab as in phase I
After completion of study treatment patients are followed periodically for 3 years
I To determine the maximum tolerated dose of vorinostat in combination with trastuzumab Herceptin in patients with metastatic or local chest wall recurrent HER-2-amplified breast cancer Phase I II To determine the toxic effects of this regimen in these patients Phase I III To determine the response rate in patients treated with this regimen Phase II
SECONDARY OBJECTIVE
I To determine the time to progression in patients treated with this regimen Phase II
OUTLINE This is an open-label multicenter dose-escalation study of vorinostat
PHASE I Patients receive oral vorinostat twice daily on days 1-14 and trastuzumab Herceptin IV over 90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of vorinostat until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity At least 6 patients are treated at the MTD
PHASE II Patients receive vorinostat at the MTD and trastuzumab as in phase I
After completion of study treatment patients are followed periodically for 3 years
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 |
|---|---|---|---|
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2009-00503 | REGISTRY | None | None |
| CDR0000449963 | None | None | None |
| E1104 | OTHER | None | None |
| E1104 | OTHER | None | None |