Phase II trial of 4'-epi-doxorubicin in metastatic colorectal carcinoma.

Twenty-three patients with metastatic colorectal carcinoma were treated with 4'-epi-doxorubicin (Epirubicin, 4'-epi-DX) 90 mg/m2 i.v. every 4 weeks. Out of 18 patients evaluable for response, 11 were previously untreated. One complete response of 21 + months was observed in a patient with rectosigmoid carcinoma. Furthermore there was one minor response in pretreated rectosigmoid series, and 6 patients had stabilization of disease. Median survival for all patients, including early deaths, was 4 months. For patients who were not pretreated and who received at least 2 cycles of therapy, median survival was 15 months. Further studies in patients with rectosigmoid carcinoma are warranted.