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Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00368875 |
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving vorinostat together with paclitaxel and bevacizumab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vorinostat when given together with paclitaxel and bevacizumab and to see how well they work in treating patients with metastatic breast cancer and/or breast cancer that has recurred in the chest wall and cannot be removed by surgery.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: bevacizumab Drug: paclitaxel Drug: vorinostat |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study of a Combination of Suberoylanilide Hydroxamic Acid (Vorinostat) Plus Paclitaxel and Bevacizumab in Patients With Advanced Metastatic and/or Local Chest Wall Recurrent Breast Cancer |
Estimated Enrollment: | 45 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a phase I, multicenter, dose-escalation study of vorinostat (SAHA) followed by a phase II, open-label study.
PROJECTED ACCRUAL: Approximately 45 patients 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 or cytologically confirmed adenocarcinoma of the breast, meeting ≥ 1 of the following criteria:
At least 1 unidimensionally or bidimesionally measurable indicator lesion
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 1 week since prior hormonal therapy
At least 10 days since prior acetylsalicylic acid (aspirin > 325 mg/day) or other nonsteroidal anti-inflammatory drugs known to inhibit platelet function, including any of the following:
No prior chemotherapy for metastatic disease
Patients previously treated with a taxane (e.g., docetaxel or paclitaxel) are eligible provided both of the following are true:
No prior histone deacetylase inhibitors (e.g., valproic acid, PXD101, FR901228, MS-275, or LAQ-824)
Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided both of the following criteria are met:
Study Chair: | Joseph A. Sparano, MD | Albert Einstein College of Medicine of Yeshiva University |
Responsible Party: | Albert Einstein Cancer Center at Albert Einstein College of Medicine ( Joseph A. Sparano ) |
Study ID Numbers: | CDR0000495242, AECM-0605291, NCI-7703 |
Study First Received: | August 24, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00368875 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage IV breast cancer recurrent breast cancer male breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Anticarcinogenic Agents Anti-Inflammatory Agents Skin Diseases Vorinostat Breast Neoplasms Breast Cancer, Male Bevacizumab Antimitotic Agents Angiogenesis Inhibitors Recurrence |
Breast Neoplasms, Male Analgesics, Non-Narcotic Paclitaxel Tubulin Modulators Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Antineoplastic Agents, Phytogenic Breast Diseases |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Growth Inhibitors Angiogenesis Modulating Agents Analgesics Breast Diseases Skin Diseases |
Growth Substances Mitosis Modulators Vorinostat Breast Neoplasms Enzyme Inhibitors Antimitotic Agents Angiogenesis Inhibitors Protective Agents Pharmacologic Actions Neoplasms Paclitaxel Analgesics, Non-Narcotic Tubulin Modulators Peripheral Nervous System Agents Antirheumatic Agents |