| Exclusion Criteria: | 1) Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma are not eligible
2) Cytotoxic chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to randomization
3) Hepatic artery embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of enrollment
4) Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)
5) Uncontrolled diabetes mellitus as defined by fasting serum glucose > 1.5 x ULN
6) Patients who have any severe and/or uncontrolled medical conditions such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction </= 6 months prior to randomization, serious uncontrolled cardiac arrhythmia; active or uncontrolled severe infection; cirrhosis, chronic active hepatitis or chronic persistent hepatitis; severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air).; active, bleeding diathesis
7) Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
8) Patients with a known history of HIV seropositivity
9) No other prior or concurrent malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for >/= 3 years
10) Female patients who are pregnant or nursing (lactating), or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes |