[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: Sachio Fushida, Takashi Fujimura, Norimasa Fukushima, Atsushi Nashimoto, Masahide Kaji, Yasuo Hirono, Kazuya Yamaguchi, Hiromi Tanemura, Motohiro Imano, Syunichi Tsujitani, Nobuhiro Kurita, Yuji Watanabe, Akira Kurita, Fuminori Goda, Tetsuo Ohta
• Journal: Gan to kagaku ryoho. Cancer & chemotherapy (Gan To Kagaku Ryoho) Vol. 34 Issue 12 Pg. 1942-5 (Nov 2007) ISSN: 0385-0684 [Print] Japan
• PMID: 18219859 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Drug Combinations
• Taxoids
• S 1 (combination)
• Tegafur
• Docetaxel
• Oxonic Acid

Topics

• Antineoplastic Combined Chemotherapy Protocols
• Docetaxel
• Drug Combinations
• Humans
• Infusions, Parenteral
• Oxonic Acid (adverse effects, therapeutic use)
• Peritoneal Neoplasms (drug therapy, secondary, surgery)
• Stomach Neoplasms (drug therapy, pathology, surgery)
• Taxoids (adverse effects, therapeutic use)
• Tegafur (adverse effects, therapeutic use)