A phase II trial of Doxorubicin HCl Liposome Injection in patients with advanced pancreatic adenocarcinoma

Summary We conducted a phase II study with doxorubicin encapsulated in a liposomal preparation (Doxorubicin HCl Liposome Injection) at a dose of 75 mg/m² administered as a one hour infusion once every three weeks. Sixteen patients were entered to the trial and 15 are evaluable for response. Hematologic toxicity was significant. The median white blood count was 1.6×10³/μl (range: 0.1–9.5), median absolute neutrophil count 0.6×10³/μl (range: 0–5.8) and median platelet count was 142.0×10³/μl (range: 20–327). Gastrointestinal toxicity was generally mild. Despite two minor responses in liver metastases with a significant decrease in CEA in one of these patients, no major responses were observed, excluding with 95% confidence, a response rate in excess of 20%.