The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Docetaxel Plus Garlic in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Official Title: A Pilot Study to Evaluate the Influence of Garlic on the Pharmacokinetics of Docetaxel in Patients With Metastatic Breast Cancer
Study ID: NCT00079170
Brief Summary: 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. PURPOSE: This clinical trial is studying how well giving docetaxel together with garlic works in treating patients with locally advanced or metastatic breast cancer.
Detailed Description: OBJECTIVES: Primary * 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. Secondary * 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
Name: Michael C. Cox, PharmD
Affiliation: NCI - Medical Oncology Branch
Role: STUDY_CHAIR