A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors
Patients will receive temozolomide orally once daily for one week, followed by a one-week
rest period. This one-week on/one week off schedule will continue for the duration of
treatment unless significant side effects develop.
Bevacizumab will be administered intravenously every other week. After eight weeks (two
cycles), a CT scan will be performed to see how treatment affected tumor growth.
Bactrim, an antibiotic, and acyclovir, an antiviral medicine, will be given in order to help
Blood tests will be done every other week to evaluate any side effects.
Once the study has been completed, a physical exam, vital signs, blood tests, and CT scan
will be performed.
Patients will remain on the study as long as they continue to receive benefit from the
treatment and there are no serious side effects.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
Matthew H. Kulke, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana-Farber Cancer Insitute||Boston, Massachusetts 02115|