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