Phase II trial of hydroxyurea, dacarbazine (DTIC), and etoposide (VP-16) in mixed mesodermal tumors of the uterus: a Gynecologic Oncology Group study.

ABSTRACT

OBJECTIVE: The purpose of this study was to evaluate the efficacy of this three-drug regimen--hydroxyurea, dacarbazine (DTIC), and etoposide (VP-16)--in patients with advanced or recurrent mixed mesodermal tumors (MMT) of the uterus who had not undergone previous chemotherapy. The study was performed as a groupwide phase II study of the Gynecologic Oncology Group. STUDY DESIGN: Thirty-three evaluable patients received hydroxyurea 2 g in divided doses on Day 1, 700 mg/m2 DTIC and 100 mg/m2 VP-16 on Day 2, and VP-16 100 mg/m2 on Days 3 and 4. Thirty-two patients were evaluable for response. Twenty-six patients had previously undergone abdominal hysterectomy and 11 had received prior radiation therapy, for whom one dose level reduction of the first course was required. RESULTS: Two patients exhibited complete response and three patients showed partial responses for an overall response rate of 15.7% (95% confidence interval 5.3-32.8%). Seventeen of 32 patients had stable disease on therapy. Toxicity was acceptable and there were no treatment-related deaths. CONCLUSION: This regimen reveals moderate activity in patients with advanced or recurrent MMT.