A PHASE-II TRIAL OF PIROXANTRONE IN ADVANCED OVARIAN-CARCINOMA AFTER FAILURE OF PLATINUM-BASED CHEMOTHERAPY - SOUTHWEST-ONCOLOGY-GROUP STUDY-8904

A phase II trial of the new anthrapyrazole piroxantrone was. conducted by the Southwest Oncology Group in advanced ovarian carcinoma, The ob jectives were to evaluate its response rate and toxicity in patients w ho had disease persistence, progression, or recurrence either during o r after platinum-containing chemotherapy, A two-stage statistical desi gn targeted accrual to 15 eligible patients if no responses were obser ved, The piroxantrone starting dose was 120 mg/m(2), with the provisio n to escalate to 150 and 180 mg/m(2). There were 16 eligible patients, all of whom had received either one (12 patients) or two (4 patients) prior platinum-containing regimens; one patient had received doxorubi cin, Fourteen of the 16 patients were enrolled either at the time of d isease persistence/progression during initial chemotherapy or with rec urrence or progression within 6 months of the previous platinum-based regimen, One to 5 cycles of piroxantrone were given. Dose escalation w as feasible in 7 patients but was prevented in the other 9 by neutrope nia. Maximum toxicity for all cycles was none or grade 1 in 2 patients ; grade 2, 5; grade 3, 8; and grade 4, 1, All but one of the grade 3 o r 4 events was from myelosuppression; there were no adverse cardiac ev ents, No responses were observed, Thus, piroxantrone appears inactive in patients with persistent, progressive, or recurrent ovarian cancer who recently had received a platinum-based regimen. (C) 1995 Academic Press, Inc.