Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027495
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2001-12-07
Brief Title:
Curcumin for the Prevention of Colon Cancer
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P00-0144 | Other Identifier | University of Michigan Cancer Center PRC | httpsreporternihgovquickSearchP30CA046592 |
| P30CA046592 | NIH | None | None |
| CCUM-9941 | OTHER | None | None |