Document Detail

A phase I/II study of gemcitabine-based chemotherapy plus curcumin for patients with gemcitabine-resistant pancreatic cancer.
MedLine Citation:
PMID:  20859741     Owner:  NLM     Status:  MEDLINE    
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 No patients were withdrawn from this study because of the intolerability of curcumin, which met the primary endpoint of the phase II study, and the median compliance rate of oral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.
Masashi Kanai; 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
Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't     Date:  2010-09-22
Journal Detail:
Title:  Cancer chemotherapy and pharmacology     Volume:  68     ISSN:  1432-0843     ISO Abbreviation:  Cancer Chemother. Pharmacol.     Publication Date:  2011 Jul 
Date Detail:
Created Date:  2011-06-27     Completed Date:  2011-08-30     Revised Date:  2013-06-03    
Medline Journal Info:
Nlm Unique ID:  7806519     Medline TA:  Cancer Chemother Pharmacol     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  157-64     Citation Subset:  IM    
Outpatient Oncology Unit, Kyoto University Hospital, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan.
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MeSH Terms
Adenocarcinoma / drug therapy*,  mortality,  physiopathology
Antineoplastic Agents / administration & dosage*,  adverse effects,  blood,  pharmacokinetics
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  therapeutic use*
Curcumin / administration & dosage*,  adverse effects,  pharmacokinetics
Deoxycytidine / administration & dosage,  adverse effects,  analogs & derivatives*
Drug Combinations
Drug Resistance, Neoplasm*
Drug Synergism
Medication Adherence
Middle Aged
Oxonic Acid / adverse effects,  therapeutic use*
Pancreatic Neoplasms / drug therapy*,  mortality,  physiopathology
Survival Rate
Tegafur / adverse effects,  therapeutic use*
Reg. No./Substance:
0/Antineoplastic Agents; 0/Drug Combinations; 150863-82-4/S 1 (combination); 17902-23-7/Tegafur; 458-37-7/Curcumin; 937-13-3/Oxonic Acid; 951-77-9/Deoxycytidine; B76N6SBZ8R/gemcitabine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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