PHASE-II EVALUATION OF 5-FLUOROURACIL AND LOW-DOSE LEUCOVORIN IN CISPLATIN-REFRACTORY ADVANCED OVARIAN-CARCINOMA

Thirty-nine women with advanced, recurrent epithelial ovarian carcinom a who failed prior treatment with a platinum-based regimen were treate d with leucovorin, 20 Mg/M2 intravenously followed by 5-fluorouracil, 425 mg/m2 intravenously, daily for 5 consecutive days every 5 weeks in a phase II trial. Partial regressions were seen in 3 of 15 (20%) meas urable disease patients, and objective regressions were seen in 3 of 1 4 (21%) evaluable/nonmeasurable disease patients. A 50% or greater dec rease in CA-125 level was observed in 3 of 10 (30%) patients with no o bjectively evaluable or measurable disease. Overall objective response rate was 23% (95% confidence interval: 11 to 39%) in all 39 patients evaluated, with a median time to progression of 3 months and overall m edian survival of 7 months. Toxicities were acceptable and consisted o f neutropenia, thrombocytopenia, stomatitis, and mild diarrhea. 5-Fluo rouracil, as administered in this protocol, had modest antitumor activ ity in cisplatin-refractory ovarian carcinoma of short duration and mi nimal toxicity. (C) 1994 Academic Press, Inc.