Clinical trial NCT00408252 (phase 2, status: terminated)
Conditions: recurrent disease, squamous cell head and neck carcinoma, palliative treatment
ICD codes: N02.6
Drugs: su011248
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Reason stopped: 
    too frequent grade 3-4 toxicities
  
Eligibility criteria:

        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.