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Clinical Trial
. 2011 Jul;68(1):157-64.
doi: 10.1007/s00280-010-1470-2. Epub 2010 Sep 22.

A phase I/II study of gemcitabine-based chemotherapy plus curcumin for patients with gemcitabine-resistant pancreatic cancer

Masashi Kanai  1 , Kenichi Yoshimura, Masanori Asada, Atsushi Imaizumi, Chihiro Suzuki, Shigemi Matsumoto, Takafumi Nishimura, Yukiko Mori, Toshihiko Masui, Yoshiya Kawaguchi, Kazuhiro Yanagihara, Shujiro Yazumi, Tsutomu Chiba, Sushovan Guha, Bharat B Aggarwal
Affiliations
Free article
Clinical Trial

A phase I/II study of gemcitabine-based chemotherapy plus curcumin for patients with gemcitabine-resistant pancreatic cancer

Masashi Kanai et al. Cancer Chemother Pharmacol. 2011 Jul.
Free article

Abstract

Purpose: Curcumin, a plant-derived natural polyphenol, could be a promising anti-cancer drug and shows synergic effects with cytotoxic agents. We evaluated the safety and feasibility of combination therapy using curcumin with gemcitabine-based chemotherapy.

Methods: Gemcitabine-resistant patients with pancreatic cancer received 8 g oral curcumin daily in combination with gemcitabine-based chemotherapy. The primary endpoint was safety for phase I and feasibility of oral curcumin for phase II study.

Results: Twenty-one patients were enrolled. No dose-limiting toxicities were observed in the phase I study and oral curcumin 8 g/day was selected as the recommended dose for the phase II study. No patients were withdrawn from this study because of the intolerability of curcumin, which met the primary endpoint of the phase II study, and the median compliance rate of oral curcumin was 100% (Range 79-100%). Median survival time after initiation of curcumin was 161 days (95% confidence interval 109-223 days) and 1-year survival rate was 19% (4.4-41.4%). Plasma curcumin levels ranged from 29 to 412 ng/ml in five patients tested.

Conclusions: Combination therapy using 8 g oral curcumin daily with gemcitabine-based chemotherapy was safe and feasible in patients with pancreatic cancer and warrants further investigation into its efficacy.

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