| Exclusion Criteria: | 1) Prior treatment with any investigational drug within the preceding 2 weeks
2) Chronic treatment with systemic steroids or another immunosuppressive agent. Patients can not receive immunization with attenuated live vaccines within one week of study entry or during study period
3) Limits for fasting lipids must be: cholesterol </= 300mg/dL and triglyceride </= 2.5x ULN. Patients may be allowed to enroll on the trial after initiation of lipid lowering agents
4) Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases (Brain imaging studies are not required if the patient does not have a history of brain mestastases and has no neurological signs or symptoms)
5) Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
6) Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction </= 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia; severely impaired lung function (oxygen dependent, CTC Grade 3 or 4 dyspnea); uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN; any active (acute or chronic) or uncontrolled infection / disorders
7) Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy ; liver disease such as cirrhosis, known chronic active hepatitis or chronic persistent hepatitis; A known history of HIV seropositivity
8) Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 and/or erlotinib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
9) Patients with an active, bleeding diathesis (if coumarin is used, weekly monitoring is recommended)
10) Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001). Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Acceptable contraception includes double-barrier methods (any double combination of: male or female condom with spermicidal gel, diaphragm, sponge, cervical cap, IUD).
11) Patients who have received prior treatment with an mTor inhibitor
12) Patients with a known hypersensitivity to erlotinib, RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients |