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Spots Global Cancer Trial Database for Docetaxel Plus Garlic in Treating Patients With Locally Advanced or Metastatic Breast Cancer

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We do not endorse or review these studies in any way.

Trial Identification

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

Conditions

Breast Cancer

Interventions

garlic
docetaxel

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States

Contact Details

Name: Michael C. Cox, PharmD

Affiliation: NCI - Medical Oncology Branch

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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