Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Cliniques Universiatires St LUC UCL
Brussels, Belgium
clinique Sainte Elisabeth
Namur, Belgium
Clinique universiataire de Mont Godinnes UCL
Yvoir, Belgium
Centre Jean Perrin
Clermont-Ferrand, France
Determine the efficacy of SU011248 alone in patients with head and neck cancer in term of overall response rate (RECIST, see statistical consideration)
Time frame: every 6 weeks
Determine the safety profile of SU011248 alone in patients with head and neck cancer.
Time frame: untill disaese progression
Determine the efficacy of SU011248 alone in patients with head and neck cancer: progression-free survival and survival.
Time frame: untill disease progression
Translational research objective:To better understand the mechanisms of sunitinib resistance by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses.
Time frame: at week 6 and at disaese progression after recist response
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centre G-f Leclerc
Dijon, France
Centre Alexis Vautrin
Nancy, France
René Gauducheau
Saint-Herblain, France
CHU Bretonneau
Tours, France
Institut Gustave Roussy
Villejuif, France