An Exploratory Biomarker Trail of Temsirolimus in Subjects With Newly Diagnosed Advanced Stage Squamous Cell Carcinoma of the Head & Neck

Inclusion Criteria:

- Subjects with newly diagnosed, advanced stage, head and neck squamous cell carcinoma
of the oral cavity, oral pharynx, hypopharynx or larynx.

- Subjects willing to undergo tumor biopsies.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

- Age >/= 18 years.

Exclusion Criteria:

- Subjects receiving anticoagulation therapy.

- Presence of unstable angina, recent myocardial infarction (within the previous 6
months), or use of ongoing maintenance therapy for life-threatening ventricular
arrhythmia.

- Prior cancer therapy (chemotherapy, hormonal therapy, radiotherapy, immunotherapy) or
investigational agent for their head and neck cancer.