Phase II trial of 10-EDAM in advanced soft tissue sarcoma. A study of the Canadian Sarcoma Group and the National Cancer Institute of Canada Clinical Trials Group.

BACKGROUND: Inoperable locally recurrent soft tissue sarcomas (STS) are incurable with chemotherapy. Therefore the National Cancer Institute of Canada Clinical Trials Group are performing phase II studies in an attempt to find better drugs. PATIENTS AND METHODS: Thirty-one evaluable patients with incurable soft tissue sarcoma were treated with the antifol 10-EDAM at a dose of 80 mg per m2/week. RESULTS: Mucositis was the most common toxicity. Only 41% of patients received > or = 90% of the planned dose time because of dose modification mainly for grade 1 mucositis. Two patients died after neutropenic episodes. Toxicity otherwise was generally mild (< grade 2). One patient had a pathologically confirmed complete response but relapsed after four months. Another had a partial response lasting 16 weeks. Eleven other patients had stabilization of disease. CONCLUSIONS: In this study, 10-EDAM was not found to be an effective agent to treat advanced soft tissue sarcoma.