Effect of Curcumin on Dose Limiting Toxicity and Pharmacokinetics of Irinotecan in Patients With Solid Tumors

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT01859858
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
21 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • curcumin — DIETARY_SUPPLEMENT
  • Irinotecan — DRUG

Study Details

Curcumin is an extract of the tumeric root that has been shown to have anti-tumor properties in laboratory studies. Curcumin, and its parent spice, turmeric (curcuma longa), are the 4th most commonly purchased dietary supplement in the U.S. Many cancer patients take curcumin during their treatment for cancer because of the purported health benefits. This research study is designed to learn more about the safety, pharmacokinetics and effectiveness of irinotecan when given in combination with curcumin in patients with metastatic colorectal cancer. The study of how the body absorbs, processes and eliminates drugs is called pharmacokinetics (PK). One of the main purposes of this study is to better understand the interaction between curcumin and irinotecan by measuring levels of irinotecan in the blood (ie. measure irinotecan PK) when a patient also takes curcumin. Information collected from this study could result in improved dosing guidelines and lead to more effective treatment of your cancer with less toxicity.

Key Dates

Start date
Jun 30, 2013
Status verified
Jun 2020
Primary completion
Oct 5, 2016
Completion
Oct 5, 2016

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: curcumin + irinotecan (part 1)
    Oral Curcumin (1, 2, 3,or 4 grams per day) for 4 days prior to irinotecan + 200 mg/m2 irinotecan IV, days 1 and 15
  • Experimental: curcumin + irinotecan (part 2)
    MTD oral Curcumin as determined in part 1 + 200 mg/m2 irinotecan IV, days 1 and 15

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
IU Simon Cancer CenterIndianapolisIndiana46202-
University of North Carolina at Chapel Hill Lineberger Comprehensive cancer CenterChapel HillNorth Carolina27509-

Find similar trials in Indianapolis, IN

By research site
IU Simon Cancer Center· Indianapolis, INUniversity of North Carolina at Chapel Hill Lineberger Comprehensive cancer Center· Chapel Hill, NC

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