Efficacy and safety of pemetrexed in combination with cisplatin for malignant pleural mesothelioma: a phase I/II study in Japanese patients

Japanese Journal of Clinical Oncology
Kazuhiko NakagawaMasahiro Fukuoka

Abstract

Pemetrexed in combination with cisplatin (Pem/Cis) is used globally for the treatment of malignant pleural mesothelioma (MPM). This Phase I/II study was conducted to determine the recommended dose (RD) (Phase I) of Pem/Cis, and evaluate the efficacy and safety (Phase II) in Japanese MPM patients. Key eligibility criteria were histologic diagnosis of MPM incurable by surgery, no prior chemotherapy, and a performance status 0-1. Under full vitamin supplementation, pemetrexed was intravenously administered on Day 1 of a 21-day cycle, followed by cisplatin. A cohort of six patients, starting from pemetrexed 500 mg/m(2) and cisplatin 75 mg/m(2) (Level 1), were studied in the dose-escalation Phase I (Step 1). The RD determined in Step 1 was carried forward into Phase II (Step 2). Planned number of patients treated with Pem/Cis was 18-38. In Step 1, 13 patients were enrolled: seven in Level 1 and six in Level -1 (pemetrexed 500 mg/m(2), cisplatin 60 mg/m(2)). Two of six evaluable patients had dose-limiting toxicities (pneumonitis and neutropenia) in Level 1, establishing Level 1 as the RD. In Step 2, 12 patients were enrolled, for a total of 19 patients treated at the RD. Seven patients achieved a partial response among these patients...Continue Reading

Citations

Aug 30, 2012·Acta Oncologica·Kenichi GembaTakumi Kishimoto
Sep 6, 2011·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Kozo KuribayashiShoji Kudoh
Nov 3, 2015·Biological & Pharmaceutical Bulletin·Takumi SakuradaKeisuke Ishizawa
Jan 9, 2018·European Journal of Hospital Pharmacy. Science and Practice·Naoko UsuiTomonori Hirashima
Jan 31, 2017·Nihon Hinyōkika Gakkai zasshi. The japanese journal of urology·Masatomo KanekoHiroo Nakauchi
Nov 2, 2018·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Takumi Sakurada

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