[A phase I study of intraperitoneal plus intravenous paclitaxel against gastric cancer with peritoneal dissemination (HGCG 0301)].
The safety of the intraperitoneal (ip) plus intravenous (iv) paclitaxel against gastric cancer with peritoneal dissemination was evaluated on a phase I dose escalation trial. Patients were treated with ip paclitaxel administered in 500 ml of normal saline before closing the abdomen, using the following dose levels: level 1, 50 mg/m(2); level 2, 60 mg/m(2); level 3, 70 mg/m(2); and level 4, 80 mg/m(2), followed by iv infusion of the same doses of paclitaxel on days 14 and 21. Twelve patients were enrolled in this study: 7 underwent reduction surgery,while 5 had only a laparotomy. ip therapy was well tolerated, and did not bring about any postoperative complications even in patients who underwent gastrectomy. Although multiple NCI/CTC grade 1 toxicities and grade 2 anemia (4 of six patients at dose levels 2 and 3) were observed, there was no dose-limiting toxicity. The overall median survival time was 316 days, and that for patients who underwent gastrectomy was 413 days. Paclitaxel at a dose of 80 mg/m(2) can be delivered by the operative ip route with acceptable toxicity profile.
Shinohara
Hisashi
H
Dept. of Surgery, Hyogo Prefectural Amagasaki Hospital.
Okamoto
Shogo
S
Nishitai
Ryuta
R
Shirakata
Yoshiharu
Y
Itoi
Kazumi
K
Yamagami
Kazuhiko
K
Taki
Yoshiro
Y
Yamamoto
Masayuki
M
Mizuno
Yoshifumi
Y
D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D005743:Gastrectomy / Q000401:mortality; D006801:Humans; D007262:Infusions, Intravenous; D007263:Infusions, Parenteral; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D010534:Peritoneal Neoplasms / Q000556:secondary*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D015996:Survival Rate; D013921:Thrombocytopenia / Q000139:chemically induced
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel