A phase I study of bi-weekly paclitaxel/cisplatin as initial therapy for advanced ovarian cancer. A study of the National Cancer Institute of Canada Clinical Trials Group.

PURPOSE Given the potential for improved outcomes, a phase I trial was initiated to develop a paclitaxel/cisplatin regimen that could be delivered every two weeks to women with newly diagnosed advanced ovarian cancer. PATIENTS AND METHODS From 1992 to 1994, 29 (28 eligible) patients were enrolled in a dose-seeking trial. All received 60 mg/m2 of cisplatin preceded by paclitaxel infused over three hours. The paclitaxel dose was excalated from an initial level of 90 mg/m2 by 10 mg/m2 increments in successive cohorts of patients. RESULTS At 120 mg/m2 of paclitaxel, the dose-limiting toxicity was granulocytopenia which prevented retreatment on time. The recommended dose level was therefore paclitaxel 110 mg/m2 infused over three hours with cisplatin 60 mg/m2, repeated bi-weekly for eight cycles. CONCLUSION This bi-weekly schedule of paclitaxel/cisplatin provides no advantage in terms of dose-intensity nor total dose of paclitaxel in comparison to more common regimens given tri-weekly.