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01-04-2007 | Phase I Studies

A phase I/II trial of celecoxib with chemotherapy and radiotherapy in the treatment of patients with locally advanced oesophageal cancer

Authors: S. J. Dawson, M. Michael, J. Biagi, K. F. Foo, M. Jefford, S. Y. Ngan, T. Leong, A. Hui, A. D. Milner, R. J. S. Thomas, J. R. Zalcberg

Published in: Investigational New Drugs | Issue 2/2007

Summary

Background: The study's aim was to determine the maximum tolerated dose (MTD) of celecoxib combined with chemoradiotherapy (CRT) for locally advanced oesophageal cancer (OC).

Methods: CRT comprised of 5FU (1000 mg/m²/day, days 1–4, weeks 1 & 5), cisplatin (75 mg/m², days 1 & 29) and radiotherapy (50 Gy in 25 fractions or 50.4 Gy in 28 fractions). Celecoxib was given daily during CRT at one of five doses (200 mg bd to 600 mg bd). Three to six patients were assigned per dose.

Results: Thirteen patients were recruited before trial closure due to external safety concerns regarding celecoxib. Median follow up was 17 months (95% CI 9 – >39). The highest administered dose was 400 mg bd (n=4) with one dose-limiting toxicity at this level: grade 3 rash. Five (38%) and 8(62%) patients had grade 3 non-haematological and haematological toxicities respectively. No grade 4 toxicities occurred. Radiological response rate was 54% (n=7: all CR). Six patients had resection with one pathological CR. Median progression-free and overall survival were 8.8 (95% CI 5.1 – >24.8) and 19.6 months (95% CI 7.3 – >39) respectively.

Conclusions: A MTD was not reached. The regimen was tolerable, indicating that celecoxib can be safely administered with CRT for locally advanced OC.

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Title: A phase I/II trial of celecoxib with chemotherapy and radiotherapy in the treatment of patients with locally advanced oesophageal cancer
Authors: S. J. Dawson
M. Michael
J. Biagi
K. F. Foo
M. Jefford
S. Y. Ngan
T. Leong
A. Hui
A. D. Milner
R. J. S. Thomas
J. R. Zalcberg
Publication date: 01-04-2007
Publisher: Kluwer Academic Publishers-Plenum Publishers
Published in: Investigational New Drugs / Issue 2/2007
Print ISSN: 0167-6997
Electronic ISSN: 1573-0646
DOI: https://doi.org/10.1007/s10637-006-9016-5

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