A multicenter phase II trial of gemcitabine and candesartan combination therapy in patients with advanced pancreatic cancer: GECA2 - PubMed (original) (raw)
Clinical Trial
doi: 10.1007/s10637-013-9972-5. Epub 2013 May 21.
Hiroyuki Isayama, Hideaki Ijichi, Takashi Sasaki, Naminatsu Takahara, Yukiko Ito, Saburo Matsubara, Rie Uchino, Hiroshi Yagioka, Toshihiko Arizumi, Tsuyoshi Hamada, Koji Miyabayashi, Suguru Mizuno, Keisuke Yamamoto, Hirofumi Kogure, Natsuyo Yamamoto, Kenji Hirano, Naoki Sasahira, Keisuke Tateishi, Minoru Tada, Kazuhiko Koike
Affiliations
- PMID: 23690239
- DOI: 10.1007/s10637-013-9972-5
Clinical Trial
A multicenter phase II trial of gemcitabine and candesartan combination therapy in patients with advanced pancreatic cancer: GECA2
Yousuke Nakai et al. Invest New Drugs. 2013 Oct.
Abstract
Background: Our retrospective study and phase I trial of gemcitabine and candesartan combination therapy suggested the inhibition of renin-angiotensin system potentially has a role in the treatment of advanced pancreatic cancer. The aim of this multicenter phase II trial was to assess the efficacy and toxicity of gemcitabine and candesartan combination therapy for advanced pancreatic cancer.
Methods: Chemotherapy-naive patients with histologically or cytologically proven advanced pancreatic cancer were enrolled. Gemcitabine was administered at a dose of 1,000 mg/m(2) over 30 min on days 1, 8, and 15 and oral candesartan at a dose of 16 mg in normotensive patients, and 8 mg initially in hypertensive patients, with dose escalation to 16 mg allowed, from days 1 to 28, repeated every 4 weeks.
Results: A total of 35 patients with advanced pancreatic cancer were enrolled. Overall response rate and disease control rate were 11.4 % and 62.9 %. The median PFS and OS were 4.3 and 9.1 months with 1-year survival rate of 34.2 %. The median PFS was significantly longer in patients receiving 16 mg compared with 8 mg of candesartan (4.6 vs. 3.5 months, p=0.031). Major severe toxicities were neutropenia (23 %), leukopenia (17 %) and thrombocytopenia (11 %). Grade 2 hypotension was observed in 3 patients (9 %) and candesartan was discontinued in 2 patients due to hypotension. Conclusions In this multicenter phase 2 trial, gemcitabine and candesartan combination therapy was tolerable but failed to demonstrate activity against advanced pancreatic cancer. (UMIN CTR: UMIN000005580).
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