A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients with Advanced Pancreatic Neuroendocrine Tumors

The purpose of this study is to compare the effects, good and/or bad, of temozolomide versus temozolomide plus capecitabine on the subjects and the subjects’advanced pancreatic neuroendocrine tumor cancer to find out which is better. In this study, subjects will get either temozolomide alone or temozolomide and capecitabine. Temozolomide and capecitabine are chemotherapy drugs, which have benefited some patients with pancreatic neuroendocrine tumors yet they have never been compared; both arms are considered investigational. These drugs are approved to treat several different types of cancer but have not been approved by the FDA to treat pancreatic neuroendocrine cancer.
In addition to learning more about these chemotherapy drugs, this study also hopes to learn more about certain molecular features of pancreatic neuroendrocrine cancer. We will be testing previously collected tumor tissue for certain changes to subjects tumor DNA. The study will specifically be looking for changes in a gene called MGMT to see if these changes predict for response to temozolomide. About 145 people will take part in this study nationwide and approximately 6 patients at the University of Arizona Cancer Center.