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

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Dietary Supplement: garlic
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: garlic|nan|
|Drug: docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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male breast cancer, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer