Phase II study of liposomal doxorubicin in patients with advanced colorectal cancer

Doxil is a liposomal preparation of doxorubicin that results in prolonged pharmacologic exposure in vivo to the active agent. We sought to test the hypothesis that this new formulation would result in improved efficacy in patients with colorectal cancer. Patients with advanced colorectal cancer who had received prior therapy were eligible for the trial. Treatment consisted of Doxil 45 mg/m2 intravenously every 3 weeks. Seventeen patients entered the trial and they received a median of two cycles of treatment. None of the patients had a partial response to treatment. Stable disease was the best response, and one patient received therapy for 17 cycles before her disease progressed. The therapy was well tolerated, with only two patients having the dose decreased because of hand-foot syndrome. Four patients experienced allergic reactions during the infusion, but with appropriate premedication and slowing of the infusion, treatment was able to be resumed without difficulty. No greater than grade I neutropenia or thrombocytopenia developed in any patient. Although Doxil was well tolerated at this dose and schedule, it was not an active agent in this group of patients. Doxil alone or in combination with other agents is worthy of further study in cancers responsive to doxorubicin.