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RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether garlic supplements affect the ability of docetaxel to kill tumor cells.
- Determine the clinical pharmacokinetic behavior of docetaxel with and without garlic tablets in patients with locally advanced or metastatic breast cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the incidence of enzyme and transporter polymorphism in patients treated with this regimen.
OUTLINE: This is a pilot, open-label study.
Patients receive docetaxel IV over 60 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. On days 5-17 of course 1, patients receive oral garlic twice daily. Patients have the option of continuing garlic tablets as long as they remain on study.
PROJECTED ACCRUAL: A total of 9-12 patients will be accrued for this study within 6 months.
Masking: Open Label, Primary Purpose: Treatment
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:32-0400
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RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary s...
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Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).
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A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...