Phase II evaluation of menogaril in advanced prostate cancer - Eastern Cooperative Oncology Group EST P-A885

Menogaril is a semisynthetic anthracycline that is less cardiotoxic than do xorubicin in a preclinical model. We conducted a phase II trial to determin e the activity of menogaril in hormone-refractory prostate cancer. Between October 1985 and November 1987, 32 eligible patients were enrolled and were divided into good- and poor-risk categories, the latter being defined by p rior radiotherapy to less than one third of the marrow-containing skeleton. Good-risk patients received a starting dose of 200 mg/m(2) by 60-minute IV infusion, whereas the poor-risk patients received 160 mg/m(2). Treatment w as repeated every 3 weeks until disease progression Menogaril caused leukop enia in 90% of patients, of whom 47% had grade m or TV toxicity, Thrombocyt openia was uncommon and mild, with only three patients (9%) experiencing gr ade II toxicity. Nonhematologic toxicity included mucositis (9%), and mild weight loss in 33% of patients. Nine patients (28%) had stable disease of 3 or more months' duration. Then were no objective partial or complete respo nses. The median time to progression for the entire group was 10 weeks, and the median survival time for all patients was 24 weeks. Because of appreci able toxicity and limited antitumor activity, further study of menogaril ca nnot be recommended in hormone-refractory prostate cancer.