Phase II study of the combination carboplatin and paclitaxel in patients with ovarian cancer.

BACKGROUND

Recently the feasibility of combining carboplatin with paclitaxel has been demonstrated in dose-finding studies. Maximum tolerated doses were 550 mg/m2 and 200 mg/m2 (three hours), respectively. We report now a phase II study in ovarian cancer patients.

PATIENTS AND METHODS

Twenty-one chemo-naïve patients with optimally (n = 6) or suboptimally (n = 15) debulked stage III or IV ovarian cancer were treated every three weeks for six courses with paclitaxel (200 mg/m2) as a three-hour infusion, immediately followed by carboplatin (550 mg/m2) as a 30-minute infusion.

RESULTS

Uncomplicated neutropenia was the principal toxicity, with mild anemia occurring regularly. As observed in the preceding phase I study, a relative lack of thrombocytopenia, generally grade III was found. Other toxicities consisted of mild neurotoxicity, nausea and vomiting, alopecia, myalgia, and bone pain. All suboptimally debulked patients responded to therapy. Overall, 12 patients underwent second-look laparoscopy, which revealed a pathologically confirmed complete remission in six. The median follow-up interval at the time of analysis was 14 months. Twelve patients are currently free of progression, at 8+ to 19 +/- months after the start of therapy.

CONCLUSION

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 versus the cisplatin/paclitaxel combination.