Phase II trial of vinorelbine in recurrent and progressive epithelial ovarian cancer

Objective. A phase II, multicenter trial was conducted to define the efficacy and safety of vinorelbine (Navelbine (vinorelbine tartrate) injection, NVB) in the treatment of advanced epithelial ovarian cancer (EOC). Methods. Patients with persistent or recurrent EOC who had received one prior platinum-based chemotherapy regimen were eligible. NVB was administered at 30 mg/m(2) as a weekly outpatient intravenous infusion. Results. Using an intent-to-treat analysis of the 38 patients who received at least one dose, 11 (29%, 95% confidence limits 15-46%) objective responses (4 complete, 7 partial) were observed. The median duration of response was 19 weeks. For all 38 patients, the: median time to treatment failure and median survival were 12 and 60 weeks, respectively, Four of the 12 patients with platinum-resistant disease responded, while 7 of the 24 patients with platinum-sensitive disease responded. Toxicity was evaluable in all 38 patients. During course 1, 15 patients required dose reduction and 21 required dose delays. Grade 3-4 granulocytopenia occurred in 23 (62%) of 37 reporting patients. Grade 3-4 anemia and thrombocytopenia occurred in 16 and 5%, respectively. The most common nonhematologic toxicities were nausea (grade 3 or less, in 34%), constipation (grade 3 or less, in 29%), and asthenia (grade 2 or less, in 24%). No life-threatening adverse effects were reported. Conclusions. NVB is an effective, palliative agent, for women with recurrent EOC. Dose-limiting granulocytopenia is substantial, yet manageable, (C) 1999 Academic Press.