drugset / Trial / NCT01859858

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

NCT01859858

Phase 1 Completed 23 enrolled UNC Lineberger Comprehensive Cancer Center
Non-randomizedSingle-groupOpen-labelBasic science

Summary

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.

Timeline

Start
2013-06
Primary completion
2016-10-05
Completion
2016-10-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Curcumin Small molecule 1 g Oral
Subject Curcumin Small molecule 2 g Oral
Subject Curcumin Small molecule 3 g Oral
Subject Curcumin Small molecule 4 g Oral
Subject Irinotecan Small molecule 200 mg/m2 Intravenous

Indications