Curcumin for the Prevention of Colon Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027495
• Other study ID #: CDR0000067916
• Secondary ID: P30CA046592CCUM-
• Status: Completed
• Phase: Phase 1
• First received: December 7, 2001
• Last updated: December 19, 2012
• Start date: December 2001
• Est. completion date: September 2007

Study information

• Verified date: December 2012
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2007
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Dietary Supplement:
• curcumin

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,