RAD001 With Weekly Cisplatin and Radiation Therapy in Patients With Locally Advanced Head and Neck Cancer

Inclusion Criteria:

• Patients with stage III/IV, locally advanced, biopsy proven squamous cell cancer of the head and neck who are planned to undergo chemoradiation as their primary treatment with curative intent. Patients with oropharynx, hypopharynx, larynx primaries, nasopharynx as well as those with documented SCC of the cervical lymph nodes, with unknown primaries, are eligible.
• Patients must have at least evaluable disease and one measurable site of disease according to RECIST criteria is desirable.
• 18 years of age or older
• Minimum of two weeks since any major surgery
• WHO performance status of 2 or less
• Adequate bone marrow, liver, and renal function as outlined in the protocol

Exclusion Criteria:

• Presence of distant metastatic disease
• Prior chemotherapy
• Prior radiation to the head and neck or adjacent anatomical site
• Chronic treatment with systemic steroids or another immunosuppressive agent
• Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
• Other malignancies within the past 3 years except for adequately treated carcinoma of the thyroid, cervix or basal or squamous cell carcinomas of the skin
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
• Uncontrolled diabetes mellitus
• A known history of HIV seropositivity
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
• Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
• Women who are pregnant or breastfeeding, or women/men able to conceive and unwilling to practice an effective method of birth control
• Patients who have received prior treatment with an mTOR inhibitor
• Patients with a known hypersensitivity to RAD001 or other rapamycins or to its excipients