NCT00079170已完成不适用
A Pilot Study to Evaluate the Influence of Garlic on the Pharmacokinetics of Docetaxel in Patients With Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Male or female
- •Menopausal Status
- •Not specified
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Neutrophil count ≥ 1,200/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin normal
- •ALT and AST ≤ 2 times ULN (3 times ULN with liver metastases)
- •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
- •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
- 另有 33 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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