Efficacy Study of Temsirolimus to Treat Head and Neck Cancer

Inclusion Criteria: * Signed written informed consent must be given prior to study inclusion * Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC) * Measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after 1st line platinum-based chemotherapy * Patients with loco-regional recurrence need to be progression free for at least 6 months after platinum-based radiochemotherapy, if locoregional recurrence is the only lesion * Cetuximab must have been included in at least one prior line of therapy * Disease is not amenable to surgery, radiotherapy or platinum-based chemotherapy * At least one measurable lesion according to RECIST (Version 1.0) criteria * Age \> 18 years * ECOG performance status 0-2 * Brain metastases require completion of local therapy with discontinuation of steroids prior to start of treatment * If of childbearing potential, willingness to use effective contraceptive method (double barrier method) for the study duration and 2 months after last dose * Willingness and ability to comply with the protocol * Adequate bone marrow function, liver and renal function Exclusion Criteria: * Live expectancy less than 3 months * Anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery * Participation in a clinical trial within the last 30 days prior to study treatment * Serious illness or medical condition other than the disease under study * Other malignancies within 3 years, with exception of HNSCC, history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix * Inability to potentially complete follow up and treatment per protocol for psychological, familial, sociological or geographical reasons * Pregnancy or breast feeding * Known allergic/hypersensitivity reaction to any component of the treatment * Concurrent treatment with oral anticoagulants * Uncontrolled diabetes: fasting serum glucose \> 2.0 ULN * Active or uncontrolled infection