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Phase II study of 5′-deoxy-5-fluorouridine (doxifluridine) in advanced malignant melanoma
Authors:Alberto  P.  Rozencweig  M.  Clavel  M.  Siegenthaler  P.  Cavalli  F.  Gundersen  S.  Bruntsch  U.  Renard  J.  Pinedo  H.
Affiliation:(1) Division d'Onco-Hématologie, Hôpital Cantonal Universitaire, CH-1211 Geneva 4, Switzerland;(2) Institut Jules Bordet, 1000 Brussels, Belgium;(3) Present address: Bristol Myers Co., Park Avenue 345, 10154 New York, N.Y., USA;(4) Centre Léon Bérard, 28, rue Laennec, F-69373 Lyon Cédex 08, France;(5) Consultation d'Oncologie, Hopital des Cadolles, CH-2000 Neuchâtel, Switzerland;(6) Servizio di Oncologia, Ospedale San Giovanni, CH-65000 Bellinzona, Switzerland;(7) Norwegian Radium Hospital & Norsk Hydro's Institute for Cancer Research Montebello, 3 Olso, Norway;(8) 5 Med Klinik, Klinikum Nurnberg Flurstraße 15, D-8500 Nürnberg, Germany;(9) EORTC Data Center, 1, rue Héger-Bordet, B-1000 Brussels, Belgium;(10) EORTC Early Clinical Trials Group, Academisch Ziekenhuis der Vrije Universiteit, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands
Abstract:Summary Forty-two patients with malignant melanoma were treated with doxifluridine, 4000 mg/m2 daily ×5, repeated every 3 weeks. The daily dose was reduced to 3000 mg/m2 in patients who had experienced severe myelosuppression with prior chemotherapy. A total of 35 patients were evaluable for response, and 25 of these received two or more courses. Two responses were observed. Toxicity mainly took the form of nausea, vomiting, stomatitis, dizziness, ataxia, and fatigue. Mild leukopenia was frequent (43%). Nadir counts <1.5×109/l leukocytes or 50×109/l platelets were seen in 7% and 2% of the courses respectively. Doxifluridine has no useful activity against malignant melanoma.
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