Evaluation of pegylated liposomal doxorubicin (Doxil) as second-line chemotherapy of squamous cell carcinoma of the cervix: A phase II study of the Gynecologic Oncology Group

Objective.Doxorubicin has reported activity in advanced and recurrent cervical cancer but hematologic toxicity has limited its use in some combinations. To determine the level of activity and potential for use in future combinations, a phase II trial of pegylated liposomal doxorubicin as second-line therapy in advanced and recurrent cervical cancer was performed.Methods.Eligible patients had squamous cell carcinoma of the cervix, measurable disease, one prior chemotherapy regimen which did not include an anthracycline, absolute neutrophil count (ANC) > 1500/μl, platelet count > 100,000/μl, and adequate hepatic function. Pegylated liposomal doxorubicin 40 mg/m2 was administered intravenously over 1 h every 4 weeks.Results.Twenty-seven patients were entered on this study. All patients were evaluable for toxicity and 26 were evaluable for response. A median of 2 courses of therapy (range 1–10) was given. No grade 4 toxicities were noted. Three patients (11.1%) had partial responses.Conclusion.Liposomal doxorubicin has limited activity, at the dose and schedule employed in previously-treated cervical cancer.