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| Sponsors and Collaborators: |
University of Michigan Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027495 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Dietary Supplement: curcumin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention |
| Official Title: | Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation |
| Study Start Date: | December 2001 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000067916, CCUM-9941, NCI-P00-0144, UMN-9941 |
| Study First Received: | December 7, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00027495 History of Changes |
| Health Authority: | United States: Federal Government |
|
colon cancer |
|
Anti-Inflammatory Agents Digestive System Neoplasms Curcumin Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Colorectal Neoplasms |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Rectal Diseases Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Curcumin |
Digestive System Neoplasms Enzyme Inhibitors Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Colorectal Neoplasms |