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Annals of Oncology 6:844-846, 1995
© 1995 European Society for Medical Oncology

research-article

Topotecan in colorectal cancer: A phase II study of the EORTC early clinical trials group

G. J. Creemers1, J. Wanders2, T. Gamucci,3, S. Vallentin4, L. Y. Dirix5, P. Schöffski6, I. Hudson7 and J. Verweij1,

1Department of Medical Oncology, Rotterdam Cancer Institute, Rotterdam
2EORTC - New Drug Development Office, Amsterdam, The Netherlands
3Divisione Oncologia Medica, Istituto Regina Elena Roma, Italy
4Department of Medical Oncology, Copenhagen University Hospital Herlev, Denmark
5Department of Medical Oncology, University Hospital Antwerpen Antwerpen, Belgium
6Abteilung Hämatologie und Onkologie, Medizinische Hochschule Hannover Hannover, Germany
7SmithKline Beecham Pharmaceuticals Harlow Essex, U.K.

Correspondence to: J. Verweij, M.D. Department of Medical Oncology Rotterdam Cancer Institute Groene Hilledijk 301 3075 EA Rotterdam The Netherlands

Background: This phase II study with the topoisomerase I inhibitor topotecan was performed to determine its clinical activity and toxicity in patients with metastatic or locally unresectable colorectal cancer

Patients and methods: Topotecan 1.5 mg/m2 was administered intravenously by 30-minute infusion for 5 days. Fifty-nine patients entered the study, 2 were considered ineligible and 57 were evaluable for response and toxicity

Results: Partial response was obtained in 4 of 57 evaluable patients (7%). The median duration of the response was 11 months (range 9.3 to 12.2). This topotecan regimen was very well tolerated. A total of 290 courses were given, with a median of 4 courses per patient (range, 1 to 18). The major toxic effects were leuko- and neutropenia (91%), grade 3–4 in 48% and 79% of courses, respectively, but with only 2 infectious complications. Other side effects were grade 1 alopecia (77%) in 46%, nausea (35%), vomiting (10%), and maculo-papular rash (6%)

Conclusions: Topotecan administered as a daily-times-five regimen has only minor activity as a single-agent therapy in colorectal cancer

phase II, topotecan, colorectal cancer


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