A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.
This is an open-label phase II, multicenter study. Eligible patients will receive SU011248
in monotherapy (37.5 mg given continuously without interruption). Tumor check-up will be
performed every 6-8 weeks. Treatment will be continued until disease progression or
unacceptable toxicities according to the patient or the investigator (the median for
treatment in renal cell study was 8 months).
Since, head and neck tumors are easily accessible for iterative biopsy, this study will
offer the opportunity to get tumor biopsies before and after SU011248. Our study will allow
translational research with biopsies at crucial timing: at baseline before any treatment, ,
during the treatment with SU011248 (cycle 1, between week 4 and 6), for patients with stable
disease or partial response, a new biopsy will be performed at the time of disease
progression to try to understand the mechanisms of tumor or resistance.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the efficacy of SU011248 alone in patients with head and neck cancer in term of overall response rate (RECIST, see statistical consideration)
every 6 weeks
Jean-Pascal H Machiels, MD PhD
Cliniques Universitaires St Luc
Belgium: Ministry of Social Affairs, Public Health and the Environment