Dose-escalated paclitaxel in 1-hour infusion with a fixed dose of cisplatin in previously untreated advanced ovarian cancer: a phase II trial of the Spanish Group for Ovarian Cancer.

摘要: This phase II trial was planned to study the efficacy and toxicity of a fixed dose cisplatin plus paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) given over 1 hour with intrapatient escalation. Patients advanced epithelial ovarian cancer (stages IIB-IV); Eastern Cooperative Oncology Group performance status or = 1000/microL, platelets were > 100,000/microL, neurotoxicity less than grade 2. Cisplatin after at 80 mg/m2. Six courses 3-week intervals planned. From May 1995 August 1996, 68 patients entered. Paclitaxel could not be escalated in six patients, another received up 200 mg/m2, 45 225 Three hundred seventy-five given: 27.7% 175 19.2% 53.1% All evaluable for toxicity, 67 response. Thirty-five had complete clinical response (51.4%), 20 partial (29.4%), stable disease (8.9%), progressed on therapy (8.9%). Overall rate 80.8 (95% confidence interval, 71.3% 90.1%). Second-look laparotomy performed 32 them (62.5%) pathologic remission. Grade 3 4 neutropenia seen 26 (38%), but only one fever. Severe thrombocytopenia seen. Peripheral (grade 1, 39.7%; 2, 42.6%; 3, 8.8%) dose-limiting. It is too early report time progression survival, these data are yet available. combination escalating doses feasible very active, high incidence peripheral may limit its use.