A phase I study of pegylated liposomal doxorubicin + gemcitabine in a fixed dose-rate infusion for the treatment of patients with recurrent ovarian cancer

5579 Background: Pegylated liposomal doxorubicin (PLD) constitutes the reference treatment for platinum-resistant (PR) ovarian cancer (OC). The combination of gemcitabine (G) + PLD seems to have additive activity in OC; however, it also has additive haematological toxicity, precluding administration of optimal dose of both drugs. Fixed dose-rate infusion (FDRI) of G improves haematological tolerance. Methods: We present data of a phase I trial using the combination of these two drugs, including G in this FDRI to ascertain whether we can enhance the therapeutic index of this combination. Inclusion criteria were: recurrent OC with a platinum-free interval 60 and with normal organ function. The starting dose of G was 1500 mg/m2, 10 mg/m2 minute, q 2 weeks (± 250 mg G titration depending on toxicity) followed by PLD 35 mg/m2 q 4 weeks. Pharmacokinetic analyses were performed on days 1 and 15 of the first cycle. Results: From Dece...