Phase II study of pegylated liposomal doxorubicin and oxaliplatin in relapsed advanced ovarian cancer

Objective. This phase II study evaluated the efficacy and safety of pegylated liposomal doxorubicin (PLD) 30 to 35 mg/m² plus oxaliplatin 70 mg/m² every 28 days in women with advanced ovarian cancer that recurred or progressed after a platinum-based regimen. Methods. 43 women received a median of 6 courses of treatment. Results. Objective response was 54% in the evaluable population and was higher in women with platinum-sensitive (67%) compared with platinum-resistant disease (29%). At a median duration of follow-up of 15.5 months, median overall survival was 15.8 months and time to tumor progression 7.3 months. Most toxicity was no greater than grade 1 or 2. There was no grade 3 or 4 palmar-plantar erythrodysesthesia. After 264 cycles administered, neutropenia was the most common cause of severe toxicity and required one patient to withdraw from the study. No cardiotoxicity was reported. Conclusion. PLD plus oxaliplatin is active and well tolerated in women with relapsed advanced ovarian cancer, regardless of platinum sensitivity.