Curcumin for the Prevention of Colon Cancer - Full Text View

Sponsor:	University of Michigan Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00027495

Purpose

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	Intervention	Phase
Colorectal Cancer	Dietary Supplement: curcumin	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Prevention
Official Title:	Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Curcumin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

December 2001

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027495

Locations

United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0930

Sponsors and Collaborators

University of Michigan Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Dean E. Brenner, MD

University of Michigan Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00027495 History of Changes
Other Study ID Numbers:	CDR0000067916, CCUM-9941, NCI-P00-0144, UMN-9941
Study First Received:	December 7, 2001
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

colon cancer

Additional relevant MeSH terms:

Colonic Neoplasms
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012