Everolimus Versus Placebo in Head and Neck Cancer

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Squamous Cell Cancer Read More

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.