A phase II trial of capecitabine (Xeloda®) in recurrent ovarian cancer

Oral capecitabine is a highly active, well-tolerated and convenient treatment for breast and colorectal cancer. This trial assessed the efficacy and safety of single-agent capecitabine in patients with previously treated ovarian cancer. A total of 29 patients with platinum-pretreated relapsed ovarian cancer were enrolled in this prospective, open-label, single-centre, phase II study. Patients received oral capecitabine 1250 mg m(−2) twice daily on days 1–14 of a 21-day cycle. Tumour response was evaluated using serum CA125. Out of 29 enrolled patients, 28 were evaluable, and a response was observed in eight patients (29%, 95% confidence interval (CI), 13–49%). Median progression-free and overall survivals were 3.7 (95% CI, 2.8–4.6) and 8.0 (95% CI, 4.1–11.8) months, respectively. After 6 months of treatment, 28% (95% CI, 13–48%) of patients remained progression-free and 62% (95% CI, 42–79%) were still alive. The most common clinical adverse events were hand–foot syndrome (HFS), nausea and diarrhoea. Grade 3 HFS occurred in 14% of patients, grade 3 vomiting in 10%. Efficacy and safety of capecitabine compare favourably with other monotherapies in platinum-refractory epithelial ovarian cancer. The convenience and improved safety profile of capecitabine compared with intravenous. regimens make it an ideal agent for administration in the outpatient setting.