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)
Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.
18 Years and up
Accepting Healthy Volunteers?
- 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.
- 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.