A phase I study investigating the safety and pharmacokinetics of highly bioavailable curcumin in cancer patients.

Cancers of the Pancreas Small Bowel and Hepatobiliary Tract
Session Type and Session Title: 
General Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Abstract Number: 
J Clin Oncol 31, 2013 (suppl 4; abstr 290)
Masashi Kanai, Yoshihiko Otsuka, Kazunori Otsuka, Takafumi Nishimura, Yukiko Mori, Shigemi Matsumoto, Yuzo Kodama, MIchiya Kawaguchi, Etsuro Hatano, Yoshiki Murakami, Atsushi Imaizumi, Tsutomu Chiba, Jun Nishihira, Hiroyuki Shibata; Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan; Theravalues Corporation, Tokyo, Japan; Department of Clinical Oncology, Akita University Graduate School of Medicine, Akita, Japan; Outpatient Oncology Unit, Kyoto, Japan; Kyoto University Hospital, Kyoto, Japan; Department of Gastroenterology and Hepatology, Kyoto University Hospital, Kyoto, Japan; Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Hepatology, Osaka City University Hospital, Osaka, Japan; Department of Gastroenterology and Hepatology, Kyoto University, Kyoto, Japan; Hokkaido Information University, Sapporo, Japan

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Abstract Disclosures


Background: Curcumin is a natural polyphenol derived from turmeric (Curcuma longa). Growing preclinical data suggests that curcumin could be a promising anticancer drug, however, poor bioavailability has been a challenging problem for its clinical application. To overcome this problem, a new form of curcumin (Theracurmin) was developed using a microparticle and surface-controlled drug delivery system. We evaluated the safety and pharmacokinetics of Theracurmin in combination with gemcitabine-based chemotherapy in cancer patients. Methods: Pancreatic or biliary tract cancer patients who failed standard chemotherapy were eligible. Planned Theracurmin doses comprised Level 0: 100 mg/body/day; Level 1: 200 mg/body/day; and Level 2: 400 mg/body/day. Level 1 was selected as a starting dose, and daily oral Theracurmin was added to standard gemcitabine-based chemotherapy. In addition to plasma curcumin levels, quality of life (QOL) score scaled according to the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30), NF-κB activity, cytokine levels (interleukin-6 and tumor necrosis factor–α), and efficacy were investigated. Results: We enrolled 16 patients between February 2011 and January 2012. Peak plasma curcumin levels (median) after Theracurmin administration were 324 ng/mL (range: 47–1,029) at Level 1 and 440 ng/mL (range: 179–1,380) at Level 2. These values were significantly higher than those in our previous data achieved using 8 g of conventional curcumin. Long systemic exposure to high concentrations of curcumin did not increase the incidence of adverse events. Interestingly, fatigue- and functioning-associated QOL scores significantly improved after Theracurmin administration (p< 0.01). Conclusions: Up to 400 mg/body/day of Theracurmin could safely increase plasma curcumin levels in cancer patients receiving gemcitabine-based chemotherapy. Clinical trial information: 000002950.