Paclitaxel in cisplatin or carboplatin-pretreated ovarian cancer. Phase II study

A phase II trial was conducted in order to assess the efficacy and toxicity of paclitaxel given at a dose of 175 mg/m2 in a 3-hour infusion every 3 weeks in patients with recurrent or cisplatin (CDDP) carboplatin-refractory ovarian cancer. Forty-two patients with a median age of 61 years (range 34-76 years) entered the study. Most patients had bulky disease. Thirty-three patients (78.5 %) presented with stage III and IV diseases. Twenty-two patients (52.3%) had previously been treated with only 1 regimen and 20 patients (47.7%) with > or = 2 regimens. The median treatment interval from the last previous therapy was 4.5 months (range 2-26 months). From 41 patients evaluable for response, 3 (7.3%) achieved a complete and 4 (9.8%) a partial response. All 3 complete and 2 out of the 4 partial responders had previously received > or = 2 chemotherapeutic regimens. Grade 3-4 toxicities included granulocytopenia (35%), which was of short duration, neurotoxicity (9.75%) and alopecia (60.9%). Two patients with grade 4 neutropenia were hospitalized due to pneumonia, which was successfully treated by broad-spectrum antibiotics and administration of G-CSF. A severe hypersensitivity reaction occurred in 1 patient early during the first cycle, resulting in discontinuation of treatment. Median relapse-free survival was 6.9 months, median time to progression 6.2 months and median survival 13.2 months. In conclusion, paclitaxel given at a dose of 175 mg/m2 as a 3-hour infusion every 3 weeks appears to be an efficacious and well-tolerated treatment in patients with recurrent or CDDP/carboplatin-refractory ovarian cancer.