A phase II, open label, monotherapy study of liposomal doxorubicin in patients with metastatic malignant melanoma

Purpose: This phase II study explored the efficacy and tolerability of pegylated liposomal doxorubicin (PLD) given on a 2 week schedule in patients with advanced malignant melanoma previously untreated by chemotherapy. Patients and methods: Patients with inoperable, advanced melanoma were treated with Pegylated liposomal doxorubicin (Caelyx®) at a dose of 20 mg/m2 every 2 weeks. Treatment cycles were repeated every 4 weeks for a maximum of 6 cycles. Patients with responding or stable disease at the end of study treatment, as assessed by using NCI CTG criteria, could continue PLD off-study. Results: PLD administered as a 2 weekly IV infusion was well tolerated with mild infusion reactions usually associated with the first infusion. Myelosuppression was mild, as was nausea and vomiting. Palmar plantar erythrodysesthesia was also uncommon using this schedule. There were no objective responses seen in the 14 evaluable patients. Enrollment was stopped as per protocol, due to lack of activity. Conclusion: PLD was well tolerated using a 2 week schedule but failed to show any activity in chemotherapy naive patients with advanced malignant melanoma.