Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Phase I Pharmacokinetic Trial of Curcuminoids Administered in a Capsule Formulation


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Principal Investigator

Dean E. Brenner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067916

NCT ID:

NCT00027495

Start Date:

December 2001

Completion Date:

September 2007

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752