[A multi-centric phase I/II study of intraperitoneal docetaxel combined with S-1 for patients with peritoneal dissemination of gastric cancer].
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.
Fushida
Sachio
S
Dept. of Gastroenterological Surgery, Kanazawa University.
Fujimura
Takashi
T
Fukushima
Norimasa
N
Nashimoto
Atsushi
A
Kaji
Masahide
M
Hirono
Yasuo
Y
Yamaguchi
Kazuya
K
Tanemura
Hiromi
H
Imano
Motohiro
M
Tsujitani
Syunichi
S
Kurita
Nobuhiro
N
Watanabe
Yuji
Y
Kurita
Akira
A
Goda
Fuminori
F
Ohta
Tetsuo
T
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*
D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid