A phase I study of paclitaxel, cisplatin, and fluorouracil (TCF) for advanced gastric cancer |
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Authors: | Takuo Hara Kenji Omura Makoto Hirano Yasuyuki Asada Yoshinori Munemoto Junichi Sakamoto |
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Affiliation: | (1) Department of Surgery, Kouseiren Takaoka Hospital, 5-10 Eiraku-cho, Takaoka, Toyama 933-8555, Japan;(2) Department of General and Cardiothoracic Surgery, Kanazawa University School of Medicine, Kanazawa, Japan;(3) Department of Surgery, Fukui Saiseikai Hospital, Fukui, Japan;(4) Department of Epidemiological and Clinical Research Information Management, Kyoto University Graduate School of Medicine, Kyoto, Japan |
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Abstract: | Purpose A phase I study of TCF therapy, which consists of paclitaxel (TXL: Taxol®) + cisplatin (CDDP) + 5-fluorouracil (5-FU), in advanced gastric cancer patients was performed to determine the recommended dose (RD) for a phase II study by checking the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of 5-FU above the fixed dose of TXL and CDDP. Methods The doses of TXL and CDDP were fixed at 80 and 25 mg/m2, respectively, while that of 5-FU was increased by 100 mg/m2 in each cohort from 300 mg/m2 (level 1) to a maximum of 600 mg/m2 (level 4). One cycle consisted of administration of these agents once per week for 3 weeks, every 4 weeks. Results A total of twelve eligible patients were included in this study. At level 1, two of three cases showed grade 3 leukopenia. At level 2, one of three cases showed grade 4 neutropenia (recovered within 3 days), and another one case showed grade 3 neutropenia. At level 3, one of three cases showed grade 3 neutropenia, and at level 4, one of three cases showed grade 4 neutropenia (recovered within 3 days), with grade 3 neutropenia in the other two cases. Even at the highest dose administered, none of the patients showed DLT. Moreover, no non-hematological toxicity judged to be DLT was observed through all levels. Six of the twelve patients had measurable disease, and the overall response rate was 83%. Conclusions Although the MTD level was not determined, based on the observed efficacy and the results of other clinical trials, the recommended doses of TXL, CDDP, and 5-FU for the TCF regimen were set as 80, 25, and 600 mg/m2, respectively, and a phase II study to investigate the clinical effectiveness and safety of this regimen has now begun. |
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Keywords: | Gastric cancer Phase I study Paclitaxel Cisplatin 5-Fluorouracil Weekly administration |
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