A phase II study evaluating the tolerability and efficacy of CAELYX (liposomal doxorubicin, Doxil) in the treatment of unresectable pancreatic carcinoma

Background: Preclinical studies of liposomal doxorubicin (CAELYX(TM)) have demonstrated significant inhibition of growth of human pancreatic cancer ex plants in nude mice. This study evaluated the efficacy of CAELYX(TM) in che motherapy-naive patients with unresectable, histologically confirmed pancre atic carcinoma. Secondary endpoints were quality of life (QOL), time to pro gression and overall survival. Patients and methods: Twenty-two patients (median age 65) were enrolled. CA ELYX(TM) was administered to the first five patients at a dose of 30 mg/m(2 ) three-weekly. Two of these patients were dose escalated to 50 mg/m(2) fou r-weekly. Subsequent patients were all treated on the latter schedule. Results: Two patients died after consenting to enter the study but before t reatment was commenced and are not included in the analysis. Sixteen patien ts were evaluable for response. No objective responses were seen. Six patie nts had stable disease. One patient experienced grade 4 toxicity with palma r plantar dysaesthesia (PPE), but continued treatment after dose reduction and delay. Four patients experienced grade 3 stomatitis and two grade 3 nau sea. Median survival from time of starting chemotherapy was 3.2 months (ran ge 21 days to 19 months) and one year survival was 10%. Eight patients comp leted at least two EORTC QLQ C-30 questionnaires. There was no significant change in either global QOL or in any functional or symptom subscale score. Conclusion:No objective responses were seen with CAELYX in this study. CAEL YX(TM) was however associated with stable disease, but data were inconclusi ve with regard to clinical benefit. It warrants further investigation in th e context of combination trials.