Everolimus Versus Placebo in Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: Everolimus (RAD 001); Placebo
Intervention description: 10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous Cell Cancer

Summary:

      Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects
      treated with everolimus versus placebo after definitive local therapy.
    

Eligibility criteria:

        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.