A phase II trial of capecitabine (Xeloda®) in recurrent ovarian 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 platinumpretreated relapsed ovarian cancer were enrolled in this prospective, open-label, single-centre, phase II study. Patients received oral capecitabine 1250 mg m À2 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 platinumrefractory 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.

A Feasibility Study of Weekly Docetaxel with Capecitabine in Ovarian Cancer: A Promising Combination of Two Active Drugs with a Potential for Synergism

“…In patients with platinum-sensitive EOC recurring 6-12 months after completion of primary chemotherapy, a Gynecologic Oncology Group study achieved only 8% response rate [27] with median TTP of 3.9 months. Another phase II study [11] on a mixed population of platinum-sensitive and platinum-resistant EOC patients showed 29% response rate though with a similar median progression-free survival of 3.7 months.…”

“…The most common side effects were hand and foot syndrome, nausea and vomiting, diarrhea, and mild myelotoxicity [11][12][13][14][15] . Docetaxel in recurrent EOC showed response rates of 23-40% [16][17][18] .…”

Vision of the Future: Capecitabine

“…Capecitabine (1,250 mg/m 2 twice daily on days 1-14 of a 21-day cycle) has shown encouraging activity as a novel monotherapy for patients with taxane and platinum pretreated ovarian cancer. In a phase II trial, 6 (32%) of 19 evaluable heavily pretreated patients (who had previously received platinum compounds and taxanes) achieved a CA-125 response according to the strict Rustin criteria [12], defined as a 50% or 75% reduction in CA-125 concentration maintained over three or four serial evaluations, respectively [13]. In addition, a further eight patients achieving stable or decreased (by >50%) serum concentrations of CA-125 lasting for at least six treatment cycles and two of nine patients (22%) with measurable disease achieved a radiologically confirmed response (one complete and one partial response).…”

Bioequivalence of Two Formulations (Innovator vs Generic) of Capecitabine in Patients with Cancer of Colon

“…Capecitabine a fluoropyrimidene carbamate rationally designed as orally administered is currently approved by the FDA (Food and Drug Administration) EMA (European Medicinal Agency) and COFEPRIS (Federal Commission against Sanitary Risks, Mexico) as adjuvant in patients with colon, colorectal [1][2][3], breast [4,5], ovarian [6,7] and pancreatic [8][9][10] cancer, in combination with other antineoplasic drugs. Capecitabine a prodrug is selectively activated by tumor cells to its cytotoxic moiety, 5-fluorouracil (5-FU), by thymidine phosphorylase, which is generally expressed at high levels in tumors [11,12].…”