Randomized Phase II Trial of Everolimus Versus Placebo as Adjuvant Therapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)

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.