RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

Inclusion Criteria: * Locally unresectable or metastatic pancreatic neuroendocrine tumor * Radiologic, operative, or pathology reports should document a pancreatic location of tumor * Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma * Patients must have at least one measurable site of disease according to RECIST criteria that has not been preciously irradiated * 18 years of age or older * Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy * Prior treatment with chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine * No Prior therapy with RAD001 or any other mTOR inhibitor * ECOG Performance status 0,1 or 2 * Life expectancy 12 weeks or more * Adequate bone marrow, liver and renal function as outlined in the protocol * Negative serum pregnancy test * Fasting serum cholesterol as outlined in protocol Exclusion Criteria: * Prior treatment with any investigational drug within the preceding 4 weeks * Chronic treatment with systemic steroids or another immunosuppressive agent * Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry * Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases * Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study * Women who are pregnant or breast feeding * Patients who have received prior treatment with an mTOR inhibitor or temozolomide * Patients with known hypersensitivity to RAD001 or other rapamycins or to its excipients * History of noncompliance to medical regimens