Torisel in Addition to Standard Chemotherapy With Radiation for Advanced Head and Neck Cancer

Inclusion Criteria:

Cohort A:

• Stage III or IVA-B HNC without prior RT except non-sm0kers with human papillomavirus (HPV) + nasopharynx and oropharynx. HPV+ oropharynx patients who have smoked regularly in the past 5 years are eligible.
• Patients with local or regional recurrence after surgery alone are eligible, as long as the recurrent stage is III or IVA-B
• Age > or = 18
• Karnofsky performance status > 70
• No severe active infection requiring intravenous antibiotics (oral antibiotics are allowable).
• Adequate renal function (creatinine < 1.5 mg/dl), based upon blood work performed within 1 month prior to registration.
• Adequate hepatic function (alkaline phosphatase and AST/ALT < 2 x ULN) based upon bloodwork performed within 1 month prior to registration.
• Adequate bone marrow function (ANC > 1.5; platelets > 100K) based upon blood work performed within one month prior to registration.
• Adequate cardiopulmonary function (no signs of acute coronary event and/or active CHF).
• No plans for other concurrent radiation therapy, chemotherapy or biologic anti-cancer therapy.

Cohort B:

• Platinum ineligible patients as defined by the multidisciplinary team.
• Stage III or IVA-B HNC without prior RT except nonsmokers with HPV + nasopharynx and oropharynx. HPV+ oropharynx patients who have smoked regularly in the past 5 years are eligible.
• Patients with local or regional recurrence after surgery alone are eligible, as long as the recurrent stage is III or IVA-B
• Age > or = 18
• KPS > 70
• No severe active infection requiring intravenous antibiotics (oral antibiotics are allowable).
• Adequate hepatic function (alkaline phosphatase and AST/ALT < 2 x ULN) based upon bloodwork performed within 1 month prior to registration.
• Adequate bone marrow function (ANC > 1.5; platelets > 100K) based upon bloodwork performed within one month prior to registration.
• Adequate cardiopulmonary function (no signs of acute coronary event and/or active CHF).
• No plans for other concurrent radiation therapy, chemotherapy or biologic anti-cancer therapy.

Exclusion Criteria:

• Current, recent (within 4 weeks of enrollment in this study) or planned participation in an experimental drug study other than this one.
• KPS < 70%
• Expected survival < 6 months
• Early stage head and neck cancer as defined as T1N0 or T2N0 by AJCC 7th edition
• Poorly controlled blood pressure, defined as systolic bp > 150 and/or diastolic bp > 100 despite medication.
• Unstable angina.
• NY Heart Association (NYHA) Grade II or greater congestive heart failure.
• History of myocardial infarction or stroke within 6 months.
• Clinically significant peripheral vascular disease.
• Evidence of bleeding diathesis or coagulopathy.
• Presence of brain or spinal cord metastases.
• Major surgical procedure(s), open biopsy or significant traumatic injury within 14 days prior to initiation of radiation therapy and/or anticipation of need for major surgical procedure during the course of the study.
• Minor surgical procedures such as needle/core biopsies, dental work, PEG placement, tracheostomy within 10 days prior to initiation of radiation therapy.
• Carotid artery exposure or other signs of impending carotid artery hemorrhage.
• History of abdominal fistula and/or gastrointestinal abdominal abscess within 6 months prior to enrollment.
• Serious, non-healing wound, ulcer, or bone fracture.
• Prior irradiation that would result in radiotherapy field "overlap."
• Requirement for high dose oral anticoagulation (i.e., goal INR > 2.0). "Mini-dose" anticoagulation may be used to assist in patency of central venous lines. Subcutaneous low-molecular weight heparin is allowable.
• No known allergies to any of the drug therapies being used in this protocol.
• No pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.