Docetaxel Plus Garlic in Treating Patients With Locally Advanced or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00079170
Recruitment Status : Completed
First Posted : March 10, 2004
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: garlic Drug: docetaxel Not Applicable

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Influence of Garlic on the Pharmacokinetics of Docetaxel in Patients With Metastatic Breast Cancer
Study Start Date : January 2004
Actual Study Completion Date : October 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the breast
  • Incurable, locally advanced or metastatic disease for which therapy with docetaxel is a reasonable option
  • No documentation of progressive disease while on docetaxel within the past 2 months
  • Brain and/or leptomeningeal metastases are allowed only if all of the following criteria are met:

    • Asymptomatic on neurological examination, including after definitive radiotherapy
    • No corticosteroid therapy to control symptoms
    • Stable lesions
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Male or female

Menopausal Status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


  • Neutrophil count ≥ 1,200/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin normal
  • ALT and AST ≤ 2 times ULN (3 times ULN with liver metastases)


  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmias


  • No known gastric emptying disorders
  • No persistent diarrhea


  • No uncontrolled diabetes mellitus
  • No active infection
  • No prior grade 3 or 4 allergic reaction attributed to compounds of similar biological composition to garlic, docetaxel, or Tween 80
  • No other concurrent uncontrolled medical condition that would preclude study participation
  • No psychiatric illness or social situation that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • Must be able to ingest oral medication
  • Lactic dehydrogenase ≤ 2 times ULN


Biologic therapy

  • At least 3 weeks since prior immunotherapy
  • No concurrent immunotherapy

    • Trastuzumab (Herceptin®) allowed after the first course of therapy at the discretion of the primary physician
  • No concurrent pegfilgrastim


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 2 weeks since prior hormonal therapy
  • No concurrent hormonal therapy
  • No concurrent megestrol during the first course of study treatment


  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • Not specified


  • More than 30 days (or 5 half-lives) since prior investigational therapy
  • No concurrent aprepitant (Emend®)
  • No concurrent or oral tetrahydrocannabinol (Marinol®) during the first course of study treatment
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or anticancer medications
  • No concurrent antiepileptic therapy
  • No concurrent immunosuppressants
  • No other concurrent herbal therapies during the first month of study participation
  • No concurrent grapefruit juice during the first month of study participation
  • No concurrent administration of the following:

    • Alprazolam
    • Cyclosporine
    • Diltiazem
    • Dofetilide
    • Erythromycin
    • Fluvoxamine
    • Itraconazole
    • Ketoconazole
    • Quinine
    • Hypericum perforatum (St. John's wort)
    • Tacrolimus
    • Theophylline
    • Warfarin
    • Zolpidem

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00079170

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Michael C. Cox, PharmD NCI - Medical Oncology Branch Identifier: NCT00079170     History of Changes
Obsolete Identifiers: NCT00076193
Other Study ID Numbers: CDR0000355083
First Posted: March 10, 2004    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: October 2006

Keywords provided by National Cancer Institute (NCI):
male breast cancer
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action