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