A Phase I/II Study of Carboplatin and Paclitaxel in Patients with Epithelial Ovarian Cancer

Background: This study was conducted to investigate the recommended dose of paclitaxel for use in combination with a fixed dose of carboplatin and to evaluate the toxicity and efficacy of carboplatin–paclitaxel combination chemotherapy in patients with epithelial ovarian cancer. Methods: One hundred and ten patients were enrolled in the Phase I/II study and 97 patients were evaluated for further analysis, excluding 13 ineligible patients or patients with infringement of protocol: 15 patients for the Phase I and 82 for the Phase II study. In the Phase I trial, we studied dose escalation using a carboplatin dose of AUC 5 and paclitaxel levels of 150, 175 and 200 mg/m 2 . The grades of toxicity of the regimen of all patients enrolled in the Phase II study (n = 82), the progression-free survival time (PFS) of optimal-debulked patients and complete responders (n = 62) and the response rate of suboptimal-debulked patients (n = 39) were investigated. Results: After observing grade 4 neutropenia in four of six patients in the paclitaxel 200 mg/m 2 administration group, we chose 175 mg/m 2 as the recommended dose of paclitaxel in this regimen. At this dose, the median of PFS and response rate were 432 days (range, 19–907 days) and 66.7%, respectively. Conclusion: Combination chemotherapy using paclitaxel 175 mg/m 2 and carboplatin AUC 5 is very well tolerated and highly effective for the treatment of ovarian cancer.