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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

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 th...

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 toxi...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    October 1 2007

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00079170

    Start Date

    January 1 2004

    End Date

    October 1 2007

    Last Update

    June 20 2013

    Active Locations (1)

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    Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, United States, 20892-1182