A PHASE-I STUDY OF BIWEEKLY 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 wa s initiated to develop a paclitaxel/cisplatin regimen that could be de livered every two weeks to women with newly diagnosed advanced ovarian cancer. Patients and methods: From 1992 to 1994, 29 (28 eligible) pat ients were enrolled in a dose-seeking trial. AU received 60 mg/m(2) of cisplatin preceded by paclitaxel infused over three hours. The paclit axel dose was excalated from an initial level of 90 mg/m(2) by 10 mg/m (2) increments in successive cohorts of patients. Results: At 120 mg/m (2) of paclitaxel, the dose-limiting toxicity was granulocytopenia whi ch prevented retreatment on time. The recommended dose level was there fore paclitaxel 110 mg/m(2) infused over three hours with cisplatin 60 mg/m(2), repeated bi-weekly for eight cycles. Conclusion: This bi-wee kly schedule of paclitaxel/cisplatin provides no advantage in terms of dose-intensity nor total dose of paclitaxel in comparison to more com mon regimens given tri-weekly.