Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Condition: Squamous Cell Head and Neck Carcinoma; Recurrent or Metastatic Disease
MeSH terms: Carcinoma; Neoplasm Metastasis; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line
      treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas.
      Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck
      cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination
      named TPEx as first-line treatment in this setting.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  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.
    

Intervention name(s): cetuximab IV; Biopsies
Intervention type(s): Biological; Other
Intervention description(s): Cetuximab 400 mg/m² over 120 minutes on day 1 of cycle 1 only.
Cetuximab dose will be 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
Cetuximab dose will be 500mg/m2 IV every 2 weeks during the maintenance therapy.
Drug: Cisplatin IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles
Drug: Docetaxel IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles
G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.; No intervention, only biopsy for translational project.
Intervention MeSH terms: Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Squamous cell carcinoma of the head and neck; recurrent or metastatic; first line chemotherapy; cetuximab; docetaxel; cisplatin; antineoplastic agents; First Line Palliative Treatment