Phase II trial of biweekly pegylated liposomal doxorubicin in recurrent platinum-refractory ovarian and peritoneal cancer.

Pegylated liposomal doxorubicin (PLD) is active in recurrent platinum-refractory ovarian and peritoneal cancer as demonstrated in a prospective-randomized trial. Dose-limiting toxicity in the US Food and Drug Administration-approved application schedule of PLD (50 mg/m2 every 4 weeks) was serious palmar-plantar erythrodysaesthesia (PPE). This phase II trial was aimed at reduction of the frequency of serious PPE without loss of efficacy by modifying both the application schedule and the total dose of PLD administered as palliative single-agent chemotherapy. Fifty patients were enrolled into this phase II trial. PLD was given via 30-min intravenous infusion at a dose of 20 mg/m2 every 2 weeks. Primary endpoint of the trial was the best response to chemotherapy. Secondary goals were progression-free survival, overall survival, and toxicity. Four complete responses and 16 partial responses were found resulting in an overall best response rate of 40.0%. The median progression-free survival in the intention-to-treat-population was 4.1 months [95% confidence interval (CI), 2.8-5.4 months], whereas the overall survival was 16.5 months (95% CI, 12.3-20.7 months). Although 17 (34.0%) patients developed some PPE, only one progressed to grade 3 (NCI-CTC version 2.0; 1998). No grade 4 toxicity occurred. PLD 20 mg/m2 biweekly is highly active in patients with recurrent platinum-refractory ovarian and peritoneal cancer. The frequency of grade 3 and grade 4 PPE was remarkably reduced in this trial, as compared with the frequency of serious PPE observed in patients who were administered the dose schedule of 50 mg/m2 every 4 weeks.

RCT Entities:   Population Interventions Outcomes