Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC2008-03 TPEx
- To determine the efficacy of TPEx combination in patients with head and neck cancer in
term of objective response rate (RECIST, see statistical consideration) Secondary
- To assess toxicities of TPEx combination
- Determine the efficacy of TPEx combination in patients with head and neck cancer: Best
Overall Response , progression-free survival and survival.
- Translational research objective:To better understand the mechanisms of chemoresistance
and to identify biomarkers by the analysis of the tumor biopsies (RNA, gene expression
profile) and protein profile (plasma samples). Exploratory analyses.
OUTLINE: This is an open-label phase II, multicenter study. Patients receive four cycles of
chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2
hours on day 1. Treatment repeats every 21 days in the absence of disease progression or
unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients
receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued
until disease progression or unacceptable toxicities according to the patient or the
investigator. Tumor check-up will be performed every 6 weeks. This study will allow
translational research with blood sample and biopsies at baseline before any treatment,
during the treatment with TPEx combination (week 6).,After completion of study treatment,
patients are followed every 2 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
objective tumor response rate
The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria
12 weeks (after completion of the fourth cycle of chemotherapy)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)