Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Curcumin may be effective in preventing the development of colon cancer.
PURPOSE: Phase I trial to determine the dose amount of curcumin that can be tolerated to help in preventing colon cancer in healthy men and women.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of curcumin as a chemopreventive agent of colon cancer in healthy subjects.
- Determine if tolerable doses of this agent in uniformly milled formulation capsules are bioavailable in these subjects.
- Determine the pharmacokinetics of this agent and two metabolites at the MTD and next lower escalated dose in these subjects.
OUTLINE: This is a dose escalation study followed by a pharmacokinetic study.
Patients receive a single oral dose of curcumin followed by a standard fatty meal.
Cohorts of 3-6 patients receive escalating doses of curcumin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients are accrued to receive curcumin in the pharmacokinetic phase of the study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
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:
- •Healthy men and women age 18 and over
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC greater than 4,000/mm3
- •Hemoglobin greater than 12 g/dL
- •Platelet count greater than 120,000/mm3
- •ALT/AST less than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 1.5 times ULN
- •Bilirubin less than 1.5 mg/dL
- •Creatinine less than 1.7 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior cancer except surgically resected basal cell or squamous cell skin cancer
- •No history of peptic ulcer disease, gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors
- •No history of unreliability or noncompliance (missing pretreatment appointment more than twice)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •At least 14 days since prior steroids
- •Radiotherapy:
- •Not specified
- •Not specified
- •At least 14 days since prior curcumin (turmeric) rich foods
- •At least 14 days since prior nonsteroidal antiinflammatory drugs (NSAIDs)
- •No chronic medications (i.e., daily for more than 28 days) except for oral contraceptives
- •No concurrent coumadin or other anticoagulants
排除标准
- 未提供