Phase I-II study of biweekly paclitaxel administration with fixed-dose-rate cisplatin in advanced gastric cancer |
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| Authors: | Kensei Yamaguchi Tomotaka Shimamura Yoshito Komatsu Akinori Takagane Takashi Yoshioka Soh Saitoh Masaki Munakata Yu Sakata Tsukasa Sato Tatsuhiro Arai Hiroshi Saitoh |
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| Affiliation: | (1) Department of Gastroenterology, Saitama Cancer Center Hospital, Komuro 818, Ina-machi, Saitama 362-0806, Japan;(2) Third Department of Internal Medicine, Hokkaido University School of Medicine, Sapporo, Japan;(3) First Department of Surgery, Iwate Medical University, Morioka, Japan;(4) Department of Clinical Oncology, Tohoku University, Sendai, Japan;(5) Department of Gastroenterology, Aomori Prefectural Central Hospital, Aomori, Japan;(6) Misawa Municipal Hospital, Misawa, Japan;(7) Department of Gastroenterology, Yamagata Prefectural Kahoku Hospital, Yamagata, Japan;(8) Department of Clinical Oncology, Tochigi Cancer Center Hospital, Utsunomiya, Japan;(9) Department of Gastroenterology, Yamagata Prefectural Central Hospital, Yamagata, Japan |
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| Abstract: | Background Both paclitaxel (TXL) and cisplatin (CDDP) show efficacy against gastric cancer. The aim of this phase I-II study was to determine the maximum tolerated dose (MTD) and to evaluate the toxicity and efficacy of combination chemotherapy with these two agents. Methods Nineteen patients entered the phase I part of the study, and 21 patients entered the phase II part. TXL infusions were administered on days 1 and 15, with a fixed 3mg/m2 dose of CDDP. Results In the phase I part of the study, we determined dose level 5, which represented a TXL dose of 18mg/m2, with CDDP 3mg/m2, to be the MTD. The recommended dose (RD) was level 4, with a TXL dose of 16mg/m2 with CDDP, 3mg/m2. In the phase II part of the study, the response rate was 25.0%; five patients had a partial response, seven had stable disease, 6 had progressive disease, and 2 were not evaluable. Grade 3 or 4 neutropenia was the most common adverse event and occurred in 65% of the patients. During treatment, 25% of the patients received granulocyte colony-stimulating factor, but febrile neutropenia was not shown in any of the patients. Major nonhematological toxicities were nausea/vomiting, anorexia, fatigue, alopecia, and sensory neuropathy. Adverse reactions of grade 3 or 4 were shown by two patients, one with anorexia (5%) and the other with sensory neuropathy (5%). Conclusion The RD was determined to be TXL 14mg/m2, with CDDP 3mg/m2. |
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| Keywords: | Paclitaxel Cisplatin Gastric cancer |
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