Everolimus Versus Placebo in Head and Neck Cancer

Inclusion Criteria:

* Diagnosis of Squamous cell carcinoma of the head and neck (stage IVa or IVb). No evidence (absence)of disease by scan.
* 18 years or older.
* Performance status 70% or better.
* Adequate marrow, renal and liver function (will be tested by labs). \_ Able give consent.

Exclusion Criteria:

* Currently receiving anti-cancer treatment.
* Major surgery or traumatic injury within 4 weeks.
* Radiotherapy related toxicities.
* Lip, nasopharynx, nasal cavity, paranasal sinus, salivary gland, skin, or thyroid primary tumors
* Receiving other investigational drugs.
* Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
* Receive immunization with attenuated live vaccines (seasonal flu shot)1 week before starting this .
* Show evidence of disease (cancer).
* Uncontrolled medical conditions such as: unstable angina, congestive heart failure, diabetes, severely impaired lung function.
* Liver disease such as cirrhosis, severe hepatic impairment, Hepatitis B or C.
* Active, uncontrolled severe infections
* Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
* Known History of HIV positivity.
* Impaired gastrointestinal function that may alter absorption of Everolimus such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection.
* Patients with an active, bleeding diathesis.
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. )
* Male patient whose sexual partner(s) are Women of child bearing potential who are not willing to use adequate.

contraception, during the study and for 8 weeks after the end of treatment

* Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus).
* Patients with a known hypersensitivity to Everolimus or other rapamycin analogues (sirolimus, temsirolimus) or to its excipients.
* History of noncompliance to medical regimens.
* Patients unwilling to or unable to comply with the protocol.