A PHASE-II TRIAL OF MERBARONE (NSC-336628) IN THE TREATMENT OF RECURRENT EPITHELIAL OVARIAN-CARCINOMA - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY

Background: Patients with recurrent epithelial ovarian carcinoma who p rogress through a cisplatin-based regimen or recur less than 6 months after discontinuing cisplatin, have limited therapeutic options. The G ynecologic Oncology Group conducted a Phase II trial of merbarone in t his patient population. Methods: Twenty-seven patients with recurrent epithelial ovarian carcinoma who had previously received one prior cis platin-based regimen were scheduled to receive 1000 mg/m(2) of merbaro ne by continuous intravenous infusion through a central line each day for five days every four weeks. Results: Of the 27 patients entered, o ne was ineligible because of wrong primary, and two never received the drug, leaving 24 patients evaluable for toxicity. Twenty of 24 were e valuable for response. The regimen was well tolerated with only one ep isode each of GOG grade 3 leukopenia (4%) or grade 4 granulocytopenia (4%). There was one episode (4%) of GOG grade 3 gastrointestinal toxic ity. Prior to increasing the infusate concentration to 4 mg/ml, there was one episode (4%) of altered mental status which, in retrospect, ma y have been secondary to iatrogenic hyponatremia. There were two parti al responses(10%) (95% confidence interval 1.2-31.7%). Conclusions: Me rbarone exhibited minimal activity at this schedule in this pretreated group of patients with epithelial ovarian carcinoma.