Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Curcumin for the Prevention of Colon Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Prevention	Completed	18 and over	NCI	CCUM-9941 NCI-P00-0144, UMN-9941, NCT00027495

Objectives

1. Determine the maximum tolerated dose (MTD) of curcumin as a chemopreventive agent of colon cancer in healthy subjects.
2. Determine if tolerable doses of this agent in uniformly milled formulation capsules are bioavailable in these subjects.
3. Determine the pharmacokinetics of this agent and two metabolites at the MTD and next lower escalated dose in these subjects.

Entry Criteria

Disease Characteristics:

• Healthy men and women age 18 and over

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

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)

Expected Enrollment

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.

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.

Trial Contact Information

Trial Lead Organizations

University of Michigan Comprehensive Cancer Center

Dean Brenner, MD, Protocol chair		Ph: 734-647-1417; 800-865-1125

Registry Information
Official Title		Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation
Trial Start Date		2001-12-05
Registered in ClinicalTrials.gov		NCT00027495
Date Submitted to PDQ		2000-05-01
Information Last Verified		2004-06-25
NCI Grant/Contract Number		P30-CA46592

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