Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Breast Diseases
+2

+ Breast Neoplasms
+ Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleA Pilot Study to Evaluate the Influence of Garlic on the Pharmacokinetics of Docetaxel in Patients With Metastatic Breast Cancer 
NCT00076193NCT00079170
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Diseases
Breast Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases
Criteria

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, United StatesSee the location
CompletedOne Study Center