Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation
- 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.
Primary Purpose: Prevention
Dean E. Brenner, MD
University of Michigan Cancer Center
United States: Federal Government
|University of Michigan Comprehensive Cancer Center
|Ann Arbor, Michigan 48109-0752