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.