PHASE-II STUDY OF THE COMBINATION CARBOPLATIN AND PACLITAXEL IN PATIENTS WITH OVARIAN-CANCER

Background: Recently the feasibility of combining carboplatin with pac litaxel has been demonstrated in dose-finding studies. Maximum tolerat ed doses were 550 mg/m(2) and 200 mg/m(2) (three hours), respectively. We report now a phase II study in ovarian cancer patients. Patients a nd methods. Twenty-one chemo-naive patients with optimally (n = 6) or suboptimally (n = 15) debulked stage III or IV ovarian cancer were tre ated every three weeks for six courses with paclitaxel (200 mg/m(2)) a s a three-hour infusion, immediately followed by carboplatin (550 mg/m (2)) as a 30-minute infusion. Results. Uncomplicated neutropenia was t he principal toxicity, with mild anemia occurring regularly. As observ ed in the preceding phase I study, a relative lack of thrombocytopenia , generally grade III was found. Other toxicities consisted of mild ne urotoxicity, nausea and vomiting, alopecia, myalgia, and bone pain. Al l suboptimally debulked patients responded to therapy Overall, 12 pati ents underwent second-look laparoscopy, which revealed a pathologicall y confirmed complete remission in six. The median follow-up interval a t the time of analysis was 14 months. Twelve patients are currently fr ee of progression, at 8+ to 19+/- months after the start of therapy. C onclusion: The carboplatin/paclitaxel combination appears to be a well -tolerated regimen, yielding high response rates. This combination has now gone forward to be evaluated in prospective randomized trials ver sus the cisplatin/paclitaxel combination.