search
Back to results

Curcumin for the Prevention of Colon Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
curcumin
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring colon cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2001
Last Updated
December 19, 2012
Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00027495
Brief Title
Curcumin for the Prevention of Colon Cancer
Official Title
Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colon cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
curcumin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean E. Brenner, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0930
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Curcumin for the Prevention of Colon Cancer

We'll reach out to this number within 24 hrs