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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.
 
ClinicalTrials.gov Identifier: NCT00027495
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 21, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Dietary Supplement: curcumin Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation
Study Start Date : December 2001
Actual Primary Completion Date : February 2004
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027495


Locations
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United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0930
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Dean E. Brenner, MD University of Michigan Rogel Cancer Center
More Information
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT00027495    
Other Study ID Numbers: CDR0000067916
P30CA046592 ( U.S. NIH Grant/Contract )
CCUM-9941 ( Other Identifier: University of Michigan Cancer Center PRC )
NCI-P00-0144
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012
Keywords provided by University of Michigan Rogel Cancer Center:
colon cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Curcumin
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action