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International Journal of Clinical Oncology

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01.10.2012 | Original Article

A phase I trial of arterial infusion chemotherapy with gemcitabine and 5-fluorouracil for unresectable biliary tract cancer

verfasst von: Tsuyoshi Hayashi, Hirotoshi Ishiwatari, Makoto Yoshida, Tsutomu Sato, Koji Miyanishi, Yasushi Sato, Masayoshi Kobune, Rishu Takimoto, Tomoko Sonoda, Junji Kato

Erschienen in: International Journal of Clinical Oncology | Ausgabe 5/2012

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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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Titel: A phase I trial of arterial infusion chemotherapy with gemcitabine and 5-fluorouracil for unresectable biliary tract cancer
verfasst von: Tsuyoshi Hayashi
Hirotoshi Ishiwatari
Makoto Yoshida
Tsutomu Sato
Koji Miyanishi
Yasushi Sato
Masayoshi Kobune
Rishu Takimoto
Tomoko Sonoda
Junji Kato
Publikationsdatum: 01.10.2012
Verlag: Springer Japan
Erschienen in: International Journal of Clinical Oncology / Ausgabe 5/2012
Print ISSN: 1341-9625
Elektronische ISSN: 1437-7772
DOI: https://doi.org/10.1007/s10147-011-0320-5

Springer Medizin

A phase I trial of arterial infusion chemotherapy with gemcitabine and 5-fluorouracil for unresectable biliary tract cancer