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Clinical Trial
. 2003 Nov 17;89(10):1843-8.
doi: 10.1038/sj.bjc.6601381.

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

P A Vasey  1 , L McMahon, J Paul, N Reed, S B Kaye
Affiliations
Clinical Trial

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

P A Vasey et al. Br J Cancer. .

Abstract

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.

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Figures

Figure 1
Figure 1
Typical responder profiles (CA125 response curves).
Figure 2
Figure 2
Progression-free survival.
Figure 3
Figure 3
Overall survival.
See this image and copyright information in PMC

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