title: [A multi-centric phase I/II study of intraperitoneal docetaxel combined with S-1 for patients with peritoneal dissemination of gastric cancer].
abstract: To determine the safety profile and activity of IP docetaxel combined with S-1 for patients with peritoneal dissemination of gastric cancer, a multi-centric phase I/II study has started. Patients with histologically confirmed peritoneal dissemination by laparoscopy or laparotomy were eligible to participate in this study, but the patients with a large amount of malignant ascites were excluded. In phase I part, the patients received variable doses of intraperitoneal docetaxel on day 1 and day 15 and 80 mg/m2 of daily oral S-1 on days 1-14 every 4 weeks. Phase I part determines the dose-limiting toxicity (DLT), maximum-tolerated dose (MTD) and recommended dose (RD), and phase II part evaluates a safe successful execution. The response rate of peritoneal dissemination was explored as the secondary endpoint. After 2 cycles, peritoneal tumor response was assessed according to the new criteria of Society for the Study of Peritoneal Dissemination in Gastric Cancer. The response criteria included the following: a decrease in ascites and change in cytology negative; at least a 50% decrease in the sum of the longest diameter of peritoneal tumor using photographs of peritoneal lesions taken to confirm an objective response before and after the treatment.
authors.affiliation: Dept. of Gastroenterological Surgery, Kanazawa University.
authors.forename: Sachio
authors.initials: S
authors.lastname: Fushida
authors.forename: Takashi
authors.initials: T
authors.lastname: Fujimura
authors.forename: Norimasa
authors.initials: N
authors.lastname: Fukushima
authors.forename: Atsushi
authors.initials: A
authors.lastname: Nashimoto
authors.forename: Masahide
authors.initials: M
authors.lastname: Kaji
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Hirono
authors.forename: Kazuya
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Hiromi
authors.initials: H
authors.lastname: Tanemura
authors.forename: Motohiro
authors.initials: M
authors.lastname: Imano
authors.forename: Syunichi
authors.initials: S
authors.lastname: Tsujitani
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Kurita
authors.forename: Yuji
authors.initials: Y
authors.lastname: Watanabe
authors.forename: Akira
authors.initials: A
authors.lastname: Kurita
authors.forename: Fuminori
authors.initials: F
authors.lastname: Goda
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Ohta
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols; D000077143:Docetaxel; D004338:Drug Combinations; D006801:Humans; D007263:Infusions, Parenteral; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000556:secondary* / Q000601:surgery; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid