A Phase II Study of Capecitabine, Temozolomide and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors
The purpose of this research is to evaluate the effectiveness and safety of a combination of capecitabine, temozolomide and bevacizumab in the treatment of advanced pancreatic neuroendocrine tumors.
- biological : bevacizumab
- drug : Temozolomide
- drug : Capecitabine
Phase: Phase 2
Ages Eligible For Study:
1. Patients must have histologically confirmed pancreatic neuroendocrine tumors that are considered well- or moderately- differentiated 2. Patients must have metastatic or unresectable disease 3. Patients with prior surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease if there is substantial clinical ambiguity regarding the nature or source of apparent metastases. 4. Prior sunitinib and everolimus will be permitted. A wash-out period of 2 weeks is required prior to first dose on this study. 5. Prior liver directed therapies will be permitted (ie. chemoembolization, radioembolization) as long as target lesions in the liver have demonstrated growth since the liver directed treatment. 6. Prior peptide receptor radionuclide therapy (PRRT) will be permitted as long as target lesions in the liver have demonstrated growth since the liver directed treatment. 7. Low-dose aspirin (<= 325 mg/d) may be continued in subjects at higher risk for arterial thromboembolic disease. 8. Patients must have a primary or metastatic lesion measurable in at least one dimension by Modified RECIST criteria v1.1 (see Section 4.2) within 4 weeks prior to entry of study. 9. Patients must have ECOG performance status of 0-2 10. Patients must be >= 18 years of age. 11. Laboratory values <= 2 weeks prior to randomization: - Absolute Neutrophil Count (ANC) >= 1.5 x 109/L (>= 1500/mm3) - Platelets (PLT) >= 100 x 10^9/L (=> 100,000/mm^3) - Hemoglobin (Hgb) >= 9 g/dL - Serum creatinine <= 1.5 x ULN - Serum bilirubin <= 1.5 x ULN - Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) <= 3.0 x ULN (<= 5.0 x ULN if liver metastases present). Note: ERCP or percutaneous stenting may be used to normalize the liver function tests. 12. Life expectancy >= 12 weeks. 13. Ability to give written informed consent according to local guidelines.