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.
Study phase: II
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Adults 18 years and older with histologically or pathologically confirmed locally unresectable or metastatic low or intermediate grade pancreatic neuroendrocrine tumor, excluding smal cell carcinoma
Primary disease category: Diabetes & Endocrine System
Sponsor: ECOG-ACRIN (national cooperative group)
Protocol number: E2211
Projected enrollment dates: April 2015 to April 2017
Official study title: A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients with Advanced Pancreatic Neuroendocrine Tumors