Trial of RAD001 and Erlotinib With Recurrent Head and Neck Squamous Cell Carcinoma

Exclusion Criteria

• •1. Prior treatment with any investigational drug within the preceding 4 weeks, concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy, or therapy with agents otherwise used in treatment of cancer (for example, methotrexate for rheumatoid arthritis)
• •2. Chronic treatment with systemic steroids or another immunosuppressive agent. Steroids will not be allowed and should be discontinued 24 hours prior to initiation of treatment on protocol. An exception for replacement steroids prescribed for adrenal insufficiency will be allowed.
• •3. Patients should not receive immunization with attenuated live vaccines during study period or within one week of study entry
• •4. Patients with metastatic disease to the brain, unless treated and controlled and the patient is off steroids and/or antiepileptics for at least 3 weeks.
• •5. Other malignancies within the past 2 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
• •6. Patients with active skin, mucosa, ocular or gastrointestinal disorders grade \> 1
• •7. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction, \</= 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia
• •8. Continued from Exclusion #7: severely impaired lung function; uncontrolled diabetes as defined by fasting serum glucose \>1.5x ULN; any active (acute or chronic) or uncontrolled infection/ disorders.; nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy; liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
• •9. A known history of HIV or AIDS-related illness or previous seropositivity for the virus
• •10. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study agents (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
• •11. Patients with any condition which impairs the ability to swallow study agent intact
• •12. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
• •13. Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential (WOCP) must have a negative urine or serum pregnancy test within 7 days prior to administration of study drugs). WOCP: A female of child bearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
• •14. (Continued from Exclusion # 13) Females must either commit to abstinence from heterosexual intercourse or use a barrier method of contraception. Oral, implantable, and injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Males must either commit to abstinence from heterosexual intercourse or use a barrier method of contraception.
• •15. Lack of resolution of all toxic manifestations of prior chemotherapy biologic therapy or radiation therapy.
• •16. Patients who have received prior treatment with an mTor inhibitor.
• •17. Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
• •18. Patients with psychiatric illness or confusional status that may impair the patient's understanding of the informed consent
• •19. Patients unwilling to or unable to comply with the protocol
• •20. Patients with any condition which impairs the ability to swallow study agent intact