Curcumin for the Prevention of Colon Cancer
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.
|Study Design:||Primary Purpose: Prevention|
|Official Title:||Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation|
|Study Start Date:||December 2001|
|Study Completion Date:||September 2007|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027495
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0930|
|Study Chair:||Dean E. Brenner, MD||University of Michigan Cancer Center|