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Curcumin for the Prevention of Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027495
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 21, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Michigan Cancer Center

December 7, 2001
January 27, 2003
December 21, 2012
December 2001
February 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00027495 on Archive Site
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Curcumin for the Prevention of Colon Cancer
Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation

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.


  • 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.

Phase 1
Primary Purpose: Prevention
Colorectal Cancer
Dietary Supplement: curcumin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2007
February 2004   (Final data collection date for primary outcome measure)


  • Healthy men and women age 18 and over



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • WBC greater than 4,000/mm3
  • Hemoglobin greater than 12 g/dL
  • Platelet count greater than 120,000/mm3


  • 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


  • Creatinine less than 1.7 mg/dL


  • 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)


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • At least 14 days since prior steroids


  • Not specified


  • Not specified


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA046592 ( U.S. NIH Grant/Contract )
CCUM-9941 ( Other Identifier: University of Michigan Cancer Center PRC )
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University of Michigan Cancer Center
University of Michigan Cancer Center
National Cancer Institute (NCI)
Study Chair: Dean E. Brenner, MD University of Michigan Cancer Center
University of Michigan Cancer Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP