Phase II study of high-dose paclitaxel in platinum-refractory epithelial ovarian cancer

The purposes of this study were to determine the efficacy of paclitaxel, using a dose of 200 mg/m² intravenous continuous infusion over 24 hours every three weeks in the treatement of platinum-refractory epithelial ovarian cancer (EOC) and to evaluate the toxicities. Eligibility criteria included: histologically proven EOC, platinum resistance, measurable disease, Zubrod performance status grade 0-2, expected survival of > 3 months and adequate hematological function. Response was assessed at three-cycle intervals or earlier if required. Twenty-one patients were recruited in this study. The response rate was 52% (2 CR, 9 PR) with a median duration of response of six months. The median progression-free interval was eight months and the median survival was 12 months. Leukopenia was the predominant toxic effect. Eighty-six percent of patients required granulocyte-colony stimulation factor (G-CSF). All patients had alopecia grade 3. In conclusion, high-dose paclitaxel is active in platinum-refractory EOC with manageable toxicities.