Abstract

The combination of paclitaxel (Taxol®) and carboplatin was evaluated in a phase I/II trial in previously untreated patients with advanced ovarian cancer. Groups of patients received different doses of paclitaxel administered by 3- or 24-h infusions, as well as different doses of carboplatin, which were calculated based on area under the concentration-time curve (AUC) dosing. The combination selected for further clinical trials was paclitaxel 175 mg m^-2 given in a 3-h infusion and carboplatin dosed to an AUC of 7.5, an outpatient regimen that can be administered on a 21-day cycle without immediate need for growth factor support. Carboplatin-paclitaxel has resulted in a clinical complete remission rate of 67% in 24 patients with measurable disease. Toxicity was mild, with few significant hematologic complications. On the basis of this trial, the Gynecologic Oncology Group has initiated a randomized trial in previously untreated patients with optimal stage III ovarian cancer to compare the carboplatin-paclitaxel regimen with cisplatin (75 mg m^-2)-paclitaxel(135 mg m^-2) by 24-h infusion.