Phase II study of 5?-deoxy-5-fluorouridine (doxifluridine) in advanced malignant melanoma

Abstract

Forty-two patients with malignant melanoma were treated with doxifluridine, 4000 mg/m2 daily X 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 less than 1.5 X 10(9)/l leukocytes or 50 X 10(9)/l platelets were seen in 7% and 2% of the courses respectively. Doxifluridine has no useful activity against malignant melanoma.

Human urinary excretion of doxifluridine and metabolites during a 5-day chemotherapeutic schedule using fluorine-19 nuclear magnetic resonance spectrometry

“…It is currently undergoing extensive clinical trials [4][5][6][7][8][9][10]. 5'dFUrd has therapeutic activity in squamous cell carcinoma of the head and neck [6] and in breast cancer [9].…”

“…Some therapeutic efficacy was detected in endometrial [9], stomach [9] and ovarian [9,11] cancers. No significant activity was noticed against renal cancer [9], non-small cell carcinoma of the lung and metastatic pulmonary tumors [7], or malignant melanoma [10].…”