International Journal of Clinical Oncology

, Volume 17, Issue 5, pp 491–497

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

  • Tsuyoshi Hayashi
  • Hirotoshi Ishiwatari
  • Makoto Yoshida
  • Tsutomu Sato
  • Koji Miyanishi
  • Yasushi Sato
  • Masayoshi Kobune
  • Rishu Takimoto
  • Tomoko Sonoda
  • Junji Kato
Original Article

DOI: 10.1007/s10147-011-0320-5

Cite this article as:
Hayashi, T., Ishiwatari, H., Yoshida, M. et al. Int J Clin Oncol (2012) 17: 491. doi:10.1007/s10147-011-0320-5

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.

Keywords

Biliary tract cancer Gemcitabine 5-Fluorouracil Arterial infusion chemotherapy Stent 

Abbreviations

5-FU

5-Fluorouracil

GEM

Gemcitabine

CDDP

Cisplatin

FUDR

Floxuridine

PS

Performance status

ECOG

Eastern Cooperative Oncology Group

CHA

Common hepatic artery

CT

Computed tomography

DLT

Dose-limiting toxicity

PD

Progressive disease

NCI-CTC

National Cancer Institute Common Toxicity Criteria

G-CSF

Granulocyte colony stimulating factor

MTD

Maximal tolerated dose

EMS

Expandable metallic stent

Copyright information

© Japan Society of Clinical Oncology 2011

Authors and Affiliations

  • Tsuyoshi Hayashi
    • 1
  • Hirotoshi Ishiwatari
    • 1
  • Makoto Yoshida
    • 1
  • Tsutomu Sato
    • 1
  • Koji Miyanishi
    • 1
  • Yasushi Sato
    • 1
  • Masayoshi Kobune
    • 1
  • Rishu Takimoto
    • 1
  • Tomoko Sonoda
    • 2
  • Junji Kato
    • 1
  1. 1.Fourth Department of Internal MedicineSapporo Medical University School of MedicineSapporoJapan
  2. 2.Department of Public HealthSapporo Medical University School of MedicineSapporoJapan

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