Pancreatic Cyst Clinical Trial
Official title:
A Pilot Study of Chemoprevention With Tamoxifen in Patients With Pre-Invasive Pancreas Mucinous Cystic Neoplasms Who Will Not Undergo Immediate Resection
This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic MCN who will not undergo immediate resection. Up to 15 subjects will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks.
This is an open-label pilot study of tamoxifen as chemoprevention in patients with pancreatic MCN who will not undergo immediate resection. Up to 15 subjects will be enrolled and take tamoxifen 20mg by mouth daily for up to 24 weeks. The primary endpoints are feasibility of tamoxifen as chemoprevention in patients with pancreatic MCN and objective response rate as assessed by MRI. This study is intended to inform the design of a subsequent trial formally powered to detect the benefit of tamoxifen in treating pancreatic MCN. The clinical features of pancreatic MCN support the influence of sex hormones in the pathogenesis of the disease. Anti-hormonal therapy may therefore constitute an effective approach to treatment of MCN and chemoprevention of pancreatic adenocarcinoma. Preliminary analyses from preclinical studies suggest that tamoxifen inhibits proliferation and apoptosis in MCN epithelial cells and fibroblasts. We hypothesize that in humans, treatment with tamoxifen will lead to cyst regression or stabilization and may spare or delay the need for resection. ;
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