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Phase II clinical trial of doxifluridine in patients with advanced ovarian cancer
Affiliation:1. Leiden University Hospital, The Netherlands;2. Antwerp University Hospital, Wilrijkstraat 10, B-2650, Edegem, Belgium;3. Netherlands Cancer Institute, Amsterdam, The Netherlands;4. Rotterdam Cancer Institute, Rotterdam, The Netherlands;5. Free University, Amsterdam, The Netherlands;6. Groningen University, Groningen, The Netherlands;7. Division of Oncology, Utrecht University Hospital, Utrecht, The Netherlands;1. Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350001, PR China;2. The United Innovation of Mengchao Hepatobiliary Technology Key Laboratory of Fujian Province, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou 350025, PR China;3. Department of Gastrointestinal Surgery, Fujian Provincial Hospital, Fuzhou 350001, PR China;4. Department of Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou 350005, PR China;1. Department of Microbiology and Cell Biology, Tokyo Metropolitan Institute of Medical Science, Tokyo, Japan;2. Department of Microbiology, Kanagawa Prefectural Institute of Public Health, Kanagawa, Japan;3. Department of Virology 1, National Institute of Infectious Diseases, Tokyo, Japan;4. Regenerative Medical Unit, T-CiRA, Takeda Pharmaceutical Company, Tokyo, Japan;5. Program in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore;6. Laboratory of Tumor Viruses, Institute for Frontier Life and Medical Sciences, Kyoto University, Kyoto, Japan;7. Kanagawa Prefectural Institute of Public Health, Kanagawa, Japan;1. Takeda Pharmaceutical Company Limited, Pharmaceutical Research Division, 26-1, Muraoka-Higashi 2-Chome, Fujisawa, Kanagawa 251-8555, Japan;2. Laboratory of Human Tumor Viruses, The Institute for Virus Research, Kyoto University, 53 Kawaharacho, Shogoin, Sakyoku, Kyoto 606-8507, Japan;3. Grad. Sch. of Biostudies, Kyoto University, 53 Kawaharacho, Shogoin, Sakyoku, Kyoto 606-8507, Japan;1. Chromatin Biology Laboratory, Institute of Cellular and Molecular Biology, Agricultural University of Georgia, Kakha Bendukidze Campus, 240 David Aghmashenebeli Alley, 0131, Tbilisi, Georgia;2. Cellular Immunology Laboratory, Institute of Cellular and Molecular Biology, Agricultural University of Georgia, Kakha Bendukidze Campus, 240 David Aghmashenebeli Alley, 0131, Tbilisi, Georgia
Abstract:
35 evaluable patients were treated with 5′-deoxy-5-fluorouridine (doxifluridine), a fluoropyrimidine derivative. All patients had been heavily pretreated and had refractory disease. Treatment with doxifluridine at a dosage of 3000 mg/m2 given intravenously for 5 successive days at 3-week intervals led to 6 partial remissions (17%). The main side-effects were central neurotoxicity, stomatitis and myelotoxicity, resulting in 2 toxic deaths. In patients with renal function disturbances, toxicity proved to be more severe. We concluded that the drug should not be used in patients with renal impairment. Because responses have been encountered, further evaluation of the drug may be warranted in the less toxic oral form.
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