Efficacy of SU 011248 in Head And Neck Carcinoma

Inclusion Criteria:

• Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation
• Recurrence must be confirmed by anatomopathology (cytology or biopsy)
• At least one measurable lesion by MRI or CT-scan
• Failed or relapsing after first line chemotherapy including a platinum* or a taxane-based chemotherapy regimen
• Patients ineligible for chemotherapy could be included in first line
• ECOG performance status 0 -2, in stable medical condition
• Patients must be able to swallow tablets
• Patients must have an expected survival of at least 3 months
• Paraffin-embedded tumor tissue available for immunohistochemistry
• Patients must be over 18 years old and must be able to give written informed consent
• Women of child-bearing age must have a negative pregnancy test
• Female patients of child-bearing age must use effective contraception until 3 months have elapsed after the last injection
• Patients must have normal organ function
• For patients with local recurrence and easily accessible tumors, acceptance of iterative biopsies to store tumor samples (Formaldehyde for immunochemistry, RNA later)
• Acceptance of giving 20 ml of blood for eventual pharmacogenomic analysis
• Acceptance of giving two plasma samples (3ml) at baseline and after 4 weeks of treatment with SU011248
• Signed informed consent prior to beginning protocol specific procedure

Exclusion Criteria:

• Non-squamous head and neck cancer
• Nasopharynx cancer
• Brain metastases
• More than two lines of chemotherapy for palliative treatment (except if chemotherapy was given as a part of a multimodal treatment given with a curative intent)
• Surgery or irradiation or investigational drugs within 4 weeks before study inclusion
• Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, …)
• Active uncontrolled coronary disease or cardiac insufficiency (Ejection fraction below 40%)
• Previous malignancy, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
• Other concomitant anticancer therapies
• Previous treatment with anti-VEGF, PDGF, or kit therapies. EGFR therapy is not an exclusion criteria.
• Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.