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Curcumin for the Prevention of Colon Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00027495
First received: December 7, 2001
Last updated: December 19, 2012
Last verified: December 2012
December 7, 2001
December 19, 2012
December 2001
February 2004   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00027495 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Primary Purpose: Prevention
Colorectal Cancer
Dietary Supplement: curcumin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
September 2007
February 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00027495
CDR0000067916
P30CA046592 ( U.S. NIH Grant/Contract )
CCUM-9941 ( Other Identifier: University of Michigan Cancer Center PRC )
NCI-P00-0144
Yes
Not Provided
Not Provided
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