A randomised study of interferon (IFN)-alpha, interleukin-2 (IL2) and 5-fluorouracil(FU) vs IFN-alpha alone in advanced

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In renal cell cancer, response rates to combination chemotherapy and to hormonal agents are low and there has thus been recent interest in biological agents. The MRC RE01 trial of IFN-alpha versus medrooxyprogesterone acetate (MPA) has recently shown survival benefit in the IFN arm. There have been several phase II studies showing the three-drug combination of interferon,interleukin and 5-flourouracil results in a median response rate of 32%. The proposed randomised multicentre trial will build on the results of the RE01 trial using IFN - alpha as the gold standard in a comparison against the new three drug combination. The primary endpoint will be overall survival; secondary endpoints will be toxicity,quality of life and progression free survival.