A phase II trial of the vitamin D analogue Seocalcitol (EB 1089) in patients with inoperable pancreatic cancer

Evans, T. , Colston, K., Lofts, F., Cunningham, D., Anthoney, D., Gogas, H., de Bono, J., Hamberg, K., Skov, T. and Mansi, J. (2002) A phase II trial of the vitamin D analogue Seocalcitol (EB 1089) in patients with inoperable pancreatic cancer. British Journal of Cancer, 86(5), pp. 680-685. (doi: 10.1038/sj/bjc/6600162)

Abstract

Inoperable cancer of the exocrine pancreas responds poorly to most conventional anti-cancer agents, and new agents are required to palliate this disease. Seocalcitol (EB1089), a vitamin D analogue, can inhibit growth, induce differentiation and induce apoptosis of cancer cell lines in vitro and can also inhibit growth of pancreatic cancer xenografts in vivo. Thirty-six patients with advanced pancreatic cancer received once daily oral treatment with seocalcitol with dose escalation every 2 weeks until hypercalcaemia occurred, following which patients continued with maintenance therapy. The most frequent toxicity was the anticipated dose-dependent hypercalcaemia, with most patients tolerating a dose of 10-15 mug per day in chronic administration, Fourteen patients completed at least 8 weeks of treatment and were evaluable for efficacy, whereas 22 patients were withdrawn prior to completing 8 weeks' treatment and in 20 of these patients withdrawal was due to clinical deterioration as a result of disease progression, No objective responses were observed, with five of 14 patients having stable disease in whom the duration of stable disease was 82 - 532 days (median= 168 days). The time to treatment failure (n=36) ranged from 22 to 847 days, and with a median survival of approximately 100 days. Seocalcitol is well tolerated in pancreatic cancer but has no objective anti-tumour activity in advanced disease, Further studies are necessary to determine if this agent has any cytostatic activity in this malignancy in minimal disease states.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Evans, Professor Jeff
• Authors: Evans, T., Colston, K., Lofts, F., Cunningham, D., Anthoney, D., Gogas, H., de Bono, J., Hamberg, K., Skov, T., and Mansi, J.
• College/School: College of Medical Veterinary and Life Sciences > School of Cancer Sciences
• Journal Name: British Journal of Cancer
• ISSN: 0007-0920