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

Objective. A phase II, multicenter trial was conducted to define the effica cy and safety of vinorelbine (Navelbine (vinorelbine tartrate) injection, N VB) in the treatment of advanced epithelial ovarian cancer (EOC). Methods. Patients with persistent or recurrent EOC who had received one pri or 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 respons es (4 complete, 7 partial) were observed. The median duration of response w as 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 patient s with platinum-resistant disease responded, while 7 of the 24 patients wit h platinum-sensitive disease responded. Toxicity was evaluable in all 38 pa tients. During course 1, 15 patients required dose reduction and 21 require d dose delays. Grade 3-4 granulocytopenia occurred in 23 (62%) of 37 report ing 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 (g rade 2 or less, in 24%). No life-threatening adverse effects were reported. Conclusions. NVB is an effective, palliative agent, for women with recurren t EOC. Dose-limiting granulocytopenia is substantial, yet manageable, (C) 1 999 Academic Press.