Phase I study of a weekly schedule of fixed-dose paclitaxel and escalating doses of cisplatin for recurrent or unresectable gastric cancer in Japan.
The authors objective was to determine the toxicities and maximum tolerated dose of a dose-dense schedule of fixed-dose paclitaxel and escalating doses of cisplatin in patients with recurrent or unresectable carcinoma of the stomach. On days 1, 8, 15, 29, 36, and 43, patients received a fixed dose of paclitaxel (80 mg/m2 over 1 hour after a short premedication) followed by a 30-minute infusion of cisplatin at dose levels of 7, 15, 20, and 25 mg/m2. Six patients were treated at each dose level, except for the dose of 25 mg/m2 cisplatin. All the patients were assessed for toxicity and 17 patients (81%) were evaluated for response. The cisplatin dose could be escalated to 25 mg/m2. At the dose of 80 mg/m2 paclitaxel and 25 mg/m2 cisplatin, all 3 patients developed dose-limiting toxicity of the gastrointestinal tract. There were no treatment-related deaths. Leukopenia grades 3 or 4 was seen in 5 patients (11.1%), but infectious complications were not encountered. Other toxicities were mild and easily managed. Weekly paclitaxel at a dose of 80 mg/m2 infused over 1 hour, followed by an infusion of 20 mg/m2 cisplatin is recommended for further study in patients with recurrent or unresectable gastric cancer.
Takahashi
Naoto
N
Department of Surgery, The Jikei University School of Medicine, Tokyo, Japan. naotot1@yahoo.co.jp
Kashiwagi
H
H
Iwabuchi
S
S
Yamazaki
Y
Y
Yanaga
K
K
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D005743:Gastrectomy; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009422:Nervous System Diseases / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010534:Peritoneal Neoplasms / Q000188:drug therapy / Q000556:secondary; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000601:surgery; D016896:Treatment Outcome
D017239:Paclitaxel; D002945:Cisplatin