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

dDoxil is a liposomal preparation of doxorubicin that results in prolonged pharmacologic exposure in vivo to the active agent. We sought to test the h ypothesis that this new formulation would result in improved efficacy in pa tients with colorectal cancer. Patients with advanced colorectal cancer who had received prior therapy were eligible for the trial. Treatment consiste d of Doxil 45 m/m(2) intravenously every 3 weeks. Seventeen patients entere d 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 be st response, and one patient received therapy for 17 cycles before her dise ase progressed. The therapy was well tolerated, with only two patients havi ng the dose decreased because of hand-foot syndrome. Four patients experien ced allergic reactions during the infusion. but with appropriate premedicat ion and slowing of the infusion, treatment was able to be resumed without d ifficulty. No greater than grade I neutropenia or thrombocytopenia develope d in any patient. Although Doxil was well tolerated at this dose and schedu le, 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 respon sive to doxorubicin.