Protocol Number: 04-C-0084
Patients 18 years of age or older with locally advanced or metastatic breast cancer may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, and possibly imaging studies, such as x-rays and CT and MRI scans to evaluate the extent of disease. Participants receive docetaxel in 4-week cycles. They receive one dose of the drug by vein (intravenous tube) over 60 minutes once a week for 3 consecutive weeks, and no drug the fourth week. They also take dexamethasone 12 hours and 1 hour before and 12 hours after the docetaxel to help prevent fluid retention caused by the drug. Patients will also receive famotidine, diphenhydramine and ondansetron prior to docetaxel. Four days after receiving the first dose of docetaxel, patients start taking garlic tablets twice a day. Patients have multiple blood draws during the first month of study to measure the docetaxel concentrations in the blood. These blood draws will enable the researchers to determine if there is any changes in the break down and elimination of docetaxel. Additional blood draws for other experimental factors will also be drawn. This may include genetic testing to determine if the patient's cells produce substances that affect the breakdown of different drugs used to fight cancer. Imaging studies are done about every 2 months to determine if the cancer is responding to the treatment. Patients are eligible for treatment until they experience severe side effects or disease progression. After 6 months, patients have a monthly chest x-ray to check for fluid around the lining of the lungs, which may develop as a result of docetaxel therapy. Docetaxel treatment is given on an outpatient basis, except for the first cycle, in which patients may spend the first night each week in the NIH Clinical Center. After the first cycle, patients may choose to be treated by a cancer doctor closer to their home. In that case, they return to the Clinical Center on the first day of every cycle for a doctors' appointment and refill of their garlic capsules.
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