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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00258349 |
RATIONALE: 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.
PURPOSE: This phase I/II 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.
Condition | Intervention | Phase |
Breast Cancer |
Drug: trastuzumab Drug: vorinostat |
Phase I Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Suberoylanilide hydroxamic acid Trastuzumab |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Trastuzumab (Herceptin) in Patients With Advanced Metastatic and/or Local Chest Wall Recurrent Her-2 Amplified Breast Cancer |
Estimated Enrollment: | 53 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Phase I
Phase II
OUTLINE: This is an open-label, multicenter, dose-escalation study of vorinostat.
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.
PROJECTED ACCRUAL: A total of 53 patients (18 for phase I, 35 for phase II) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Metastatic or chest wall recurrent disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan
No untreated brain metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Radiotherapy
Surgery
Other
Show 45 Study Locations |
Eastern Cooperative Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Ramona Swaby, MD | Fox Chase Cancer Center |
Investigator: | Joseph A. Sparano, MD | Albert Einstein College of Medicine of Yeshiva University |
Investigator: | Lori J. Goldstein, MD | Fox Chase Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000449963, ECOG-E1104 |
First Received: | November 22, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00258349 |
Health Authority: | United States: Federal Government |
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