A phase I study of combination therapy of the oral fluorinated pyrimidine compound S-1 with low-dose cisplatin twice-a-week administration (JFMC27-9902 Step2) in patients with advanced gastric cancer using a continual reassessment method

Japanese Journal of Clinical Oncology
Satoshi MoritaKosei Hirakawa

Abstract

We conducted a Phase I study to evaluate the safety and efficacy of a combination of S-1 with semi-weekly low-dose cisplatin in patients with unresectable/recurrent gastric cancer to determine the recommended dose (RD) for a subsequent Phase II study. S-1 was administered orally at 80-120 mg/body/day based on body surface area. One cycle consisted of the consecutive administration of S-1 for 28 days followed by 14 days rest. Three dose levels, 7.5, 10, and 15 mg/m(2)/day, were set for cisplatin, which was administered twice-a-week for 4 weeks followed by 2 weeks of rest in each cycle. Dose-limiting toxicity (DLT) data were continually monitored to enable decisions regarding cisplatin dose escalation and deescalation based on a new dose-finding algorithm using a continual reassessment method (CRM). The CRM target toxicity level to estimate the RD was set at 20%. Eight and five patients were treated at cisplatin dose levels of 10 and 15 mg/m(2)/day, respectively. Two DLTs occurred at both dose levels. On the basis of this data, the CRM estimated the RD to be 10 mg/m(2)/day of cisplatin. Three patients of eight patients treated with 10 mg/m(2)/day of cisplatin exhibited a confirmed partial response during the treatment period. For...Continue Reading

Citations

Feb 4, 2011·Annals of Oncology : Official Journal of the European Society for Medical Oncology·S TerakuraUNKNOWN Nagoya Blood and Marrow Transplantation Group
Jul 16, 2013·Gastric Cancer : Official Journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association·Toshikazu MoriwakiIchinosuke Hyodo
Oct 27, 2009·Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy·Shinsuke Suzuki, Kazuo Ishikawa
Jun 14, 2016·BioPsychoSocial Medicine·Yojiro UmezakiAkira Toyofuku
Jul 2, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Alexia Iasonos, John O'Quigley

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