Carboplatin and paclitaxel in ovarian cancer.

A phase I trial of carboplatin plus paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) therapy for untreated patients with advanced ovarian cancer has been completed, demonstrating that these drugs can be combined in full doses with acceptable toxicity. This combination has now gone forward to be evaluated in prospective randomized trials. The Gynecologic Oncology Group will be doing a randomized trial comparing therapy with cisplatin plus paclitaxel versus carboplatin plus paclitaxel in patients with optimal stage III ovarian cancer. Patients with limited-stage disease but with poor prognostic features will be randomly assigned to receive either three or six cycles of carboplatin plus paclitaxel. Carboplatin will be dosed using the Calvert formula at an area under the plasma concentration versus time curve of 7.5 and paclitaxel will be administered at a dose of 175 mg/m2 by 3-hour continuous infusion. Cycles are planned to be administered every 21 days without granulocyte-colony stimulating factor.