PHASE-II TRIAL OF ORAL ALTRETAMINE FOR RELAPSED OVARIAN-CARCINOMA - EVALUATION OF DEFINING RESPONSE BY SERUM CA125

Purpose: A phase II study was performed of oral altretamine in 71 pati ents with ovarian carcinoma who entered clinical complete remission wi th CA125 level, less than 35 U/mL after initial or second-line chemoth erapy, and relapsed more than 5 months later. Response was compared be tween standard and CA125-based criteria. Patients and Methods: Altreta mine 260 mg/m(2) was given in divided doses daily for 14 days per mont h. Response was evaluated according to European Organization for Resea rch and Treatment of Cancer (EORTC) criteria in 45 of 66 eligible pati ents, Response was assessed according to precise CA125 criteria in 51 patients based on either a confirmed greater than or equal to 50% or g reater than or equal to 75% decrease in CA125 levels. Results: A combi nation of domperidone, dexamethasone, and chlorpromazine at night cont rolled toxicity in most patients, which was mainly nausea (National Ca ncer Institute criteria grade 2 or 3 in 27), vomiting (grade 2 or 3 in 19, grade 4 in one), and tiredness (grade 2 or 3 in 15), Responses (c omplete plus partial) were seen in 18 (40%; 95% confidence interval [C I], 25.4% to 54.6%) of those evaluated according to EORTC criteria and in 20 (39%; 95% CI, 25.5% to 52.9%) of those evaluated according to C A125 level, The overall response rate was 26 of 57 (45.6%) and was rel ated sc treatment-free interval: 6 to 12 months, 35%; 12 to 24 months, 52%; and greater than 24 months, 67%, The medium duration of response wets 8 months. Conclusion: Oral altretamine is a useful agent in pati ents who relapse after previously responsive ovarian cancer, Response evaluation by a strict CA125 definition gave a similar estimate of the efficacy of altretamine as EORTC criteria. (C) 1997 by American Socie ty of Clinical Oncology.