Taxol (paclitaxel) safety in patients with platinum pretreated ovarian carcinoma: an interim analysis of a phase II multicenter study.

The objective of this phase II, multicenter, prospective study was to evaluate the safety and the response rate of paclitaxel administered to patients with ovarian cancer. Eligible patients had histologically proven ovarian carcinoma and measurable or evaluable disease and had received at least one platinum-containing regimen and no more than three prior chemotherapy regimens. Paclitaxel was given as a continuous intravenous (i.v.) infusion over 3 hours every 3 weeks. Dose was determined by the number of prior chemotherapy regimens. Patients with one or two prior chemotherapy regimens received 175 mg/m2 (group A) and patients with three prior chemotherapy regimens 135 mg/m2 paclitaxel (group B) after premedication. Treatment was repeated every 3 weeks. An interim safety analysis for the first 99 evaluable patients, 72 treated with 175 mg/m2 and 27 treated with 135 mg/m2 paclitaxel, is reported here. Median number of courses analyzed per patient was four (range, 1 to 6) in the two groups, for a total of 393 courses evaluable for toxicity (286 in group A, 107 in group B). World Health Organization (WHO) grade 3-4 neutropenia was observed in 29.6% of courses in group A and in 23.3% in group B. Two group A patients, 1 at courses 3 and 4 and 1 at course 6, experienced WHO grade 2 fever or infection associated with a WHO grade 4 neutropenia.(ABSTRACT TRUNCATED AT 250 WORDS)