A phase I study of cisplatin i.p. and carboplatin i.v. with G-CSF in patients with ovarian cancer

We conducted a dose-escalation study with a fixed dose of intraperitoneal cisplatin and G-CSF support of carboplatin using the Calvert formula in epithelial ovarian cancer. Twenty-five patients were entered in this study. On day 1, carboplatin was administered intravenously at target AUCs of 4, 5, 6, and 7. On day 2, cisplatin was given i.p. in 70 mg/m2. G-CSF, 50 microgram/m2, was administered subcutaneously from day 7 to 16. Cycles were scheduled to be delivered every four weeks. A total of 85 cycles were administered. The maximum tolerated dose was AUC 7 mg/ml x min of carboplatin. The overall response rate was 80% (12/15). The combination in this regimen is feasible, and a phase II study of this regimen is warranted.