A phase I trial of arterial infusion chemotherapy with gemcitabine and 5-fluorouracil for unresectable biliary tract cancer |
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Authors: | Tsuyoshi Hayashi Hirotoshi Ishiwatari Makoto Yoshida Tsutomu Sato Koji Miyanishi Yasushi Sato Masayoshi Kobune Rishu Takimoto Tomoko Sonoda Junji Kato |
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Affiliation: | Fourth Department of Internal Medicine, Sapporo Medical University School of Medicine, South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan, thayashi69@sapmed.ac.jp. |
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Abstract: | Background Many clinical trials have been conducted with gemcitabine- or 5-fluorouracil-based regimens as treatment for unresectable biliary tract cancer; however, the results remain unsatisfactory. Because further therapeutic improvements are required, we conducted a phase I study of arterial infusion chemotherapy using a combination of gemcitabine and 5-fluorouracil. Methods In the first 3 cohorts, patients were to receive an arterial infusion of gemcitabine 600, 800 or 1000?mg/m2, respectively, over 30?min on days 1 and 15, plus a continuous arterial infusion of 5-fluorouracil 300?mg/m2/day on days 1–5 and 15–19. In the final cohort, patients were to receive an arterial infusion of gemcitabine 1000?mg/m2 over 30?min on days 1 and 15, plus 5-fluorouracil 400?mg/m2/day on days 1–5 and 15–19. Results Eighteen patients were enrolled. In the final cohort, three of six patients experienced grade 3 non-hematological toxicities (cholecystitis, cellulitis and pneumonia). Thus, we determined the maximum tolerated doses of gemcitabine and 5-fluorouracil in arterial infusion chemotherapy to be 1000 and 400?mg/m2, respectively. Conclusion This regimen of gemcitabine and 5-fluorouracil is tolerable and warrants further investigation in biliary tract cancer. |
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