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

Protocol
13-194
Full Title
A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients with Advanced Pancreatic Neuroendocrine Tumors (ECOG E2211)
Phase
II
Purpose

The purpose of this study is to evaluate the use of temozolomide alone and with capecitabine in patients with pancreatic neuroendocrine tumors that have spread and are continuing to grow. Both drugs are approved for the treatment of other types of cancer, but their use in this study is considered investigational. They have benefited some patients with pancreatic neuroendocrine tumors, but have never been compared.

In the study, patients will be randomly assigned to receive temozolomide alone or temozolomide and capecitabine. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic pancreatic neuroendocrine tumor.
  • Patients may not have received prior therapy with temozolomide, capecitabine, 5-FU, or dacarbazine.
  • Patients may have had prior therapy with everolimus or sunitinib, as long as it was completed within 4 weeks of entering the study.
  • Patients may be receiving treatment with somatostatin analogues, as long as they have been on a stable dose of the drug for 8 weeks and continued to experience cancer growth while taking that dose.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Diane Reidy-Lagunes at 646-888-4185.

Disease(s)
Upper Gastrointestinal: Neuroendocrine
Upper Gastrointestinal: Pancreatic Cancer
Locations
Related Diseases