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

June 18, 2013 updated by: National Cancer Institute (NCI)

A Pilot Study to Evaluate the Influence of Garlic on the Pharmacokinetics of Docetaxel in Patients With Metastatic Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Male or female

Menopausal Status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

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

Hepatic

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

Renal

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

Cardiovascular

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

Gastrointestinal

  • No known gastric emptying disorders
  • No persistent diarrhea

Other

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • Not specified

Other

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael C. Cox, PharmD, NCI - Medical Oncology Branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

March 8, 2004

First Submitted That Met QC Criteria

March 9, 2004

First Posted (Estimate)

March 10, 2004

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000355083
  • NCI-04-C-0084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe