Curcumin for the Prevention of Colon Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Patients are followed at 24, 36, 48, and 72 hours. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the dose escalation phase and then 12 additional patients will be accrued for the pharmacokinetic phase of this study within 3 months.

Official Title
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Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: curcumin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Healthy men and women age 18 and over PATIENT CHARACTERISTICS: Age: 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 Hepatic: 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 Renal: Creatinine less than 1.7 mg/dL Other: 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 Surgery: Not specified Other: 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

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: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: curcumin|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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colon cancer