Continuous-infusion floxuridine and alpha interferon in metastatic renal cancer: A national biotherapy study group phase II study

Eighteen patients with advanced renal cancer were treated with 0.15 mg/kg/d ay floxuridine by continuous intravenous infusion for 14 days with 3 millio n IU/m(2)/day alpha interferon subcutaneously three rimes weekly. Treatment cycles were repeated every 28 days. Floxuridine dosages were escalated to a maximum of 0.2 mg/kg/day and alpha interferon dosages were escalated to a maximum of 6 million IU/m2/day depending on patient tolerability. A total of 49 treatment courses were administered with a median of 2.7 courses per patient. Of 14 assessable patients, there were no complete or partial respo nses. Eight patients (57%) had stabilization of disease. The median surviva l for patients with stable disease was 20.9 months and for all 18 patients was 7.2 months. Grades 3 and 4 toxicities included diarrhea (44%), nausea/v omiting (28%), mucositis (11%), fever (22%), and fatigue (50%). Dose-limiti ng toxicities were primarily gastrointestinal symptoms. There were no treat ment-related deaths. This combination in the dose schedule used did not res ult in any significant objective tumor response but was associated with con siderable toxicity.