(CALGB 80701) Randomized Phase II Study of Everolimus Alone Versus Everolimus Plus Bevacizumab in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors
Title (CALGB 80701) Randomized Phase II Study of Everolimus Alone Versus Everolimus Plus Bevacizumab in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors
Contact CG
Principal Investigator Renuka Iyer, MD
Study Number 188710
Phase2
Summary Patients with metastatic pancreatic neuroendocrine tumors currently have few treatment options. Symptoms of hormonal excess can often be managed with somatostatin analogs; however, objective radiographic tumor regression following treatment with such agents is rare. Recent studies have suggested that a number of novel agents have activity in neuroendocrine tumors. Among the most promising of these agents are VEGF pathwayinhibitors and inhibitors of mTOR. The current study will evaluate the anti-tumor activity of two promising regimens (everolimus alone or in combination with bevacizumab) in pancreatic neuroendocrine tumors, providing a basis for future phase III studies in this disease setting.
Eligibility
- Histologic Documentation: Patients must have histologic documentation of well differentiated or moderately differentiated neuroendocrine tumor from either a primary or metastatic site.
- Patients must have evidence of disease (measurable or non-measurable) with evidence of progression within the past 12 months.
- No prior treatment with bevacizumab, everolimus or other mTOR inhibitors.
- Other prior treatments, including but not limited to prior cytotoxic chemotherapy, alpha interferon, tyrosine kinase inhibitors, external beam radiation therapy, and radiopeptide therapy are allowed. There is no limit on the number of prior treatment regimens. Any prior treatment (with the exception of octreotide) must be completed at least 4 weeks prior to initiation of treatment.
- No active or severe liver disease (e.g., acute or chronic hepatitis, cirrhosis).
- No clinical evidence of brain metastases or carcinomatous meningitis.
- Patients with a history of severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or oxygen saturation that is 88% or less at rest on room air are excluded.
