Taking into account previous results with epirubicin in colorectal cancer, in January, 1985, an oriented Phase II trial was started in patients with measurable rectal cancer, previously untreated with chemotherapy. Ten patients were treated with 80 mg/m2 every 3 weeks, and another 10 patients with 100 mg/m2 every 3 weeks. One patient from the 80 mg/m2 group and 3 from the 100 mg/m2 group reached partial remission for 4, 9+, 15 and 72+ weeks. Median survival for all patients was 16 months. Hematological toxicity was not a limiting factor. Anemia was significantly more frequent in the higher dose group; clinical cardiotoxicity was not observed. The incidences of nausea/vomiting and mucositis were low. Considering the low toxicity and the responses observed, additional studies seem to be indicated with an increase in the epirubicin dose.