Spots Global Cancer Trial Database for Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

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Trial Identification

Brief Title: Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Official Title: Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC 2008-03 TPEx

Study ID: NCT01289522

Conditions

Squamous Cell Head and Neck Carcinoma

Recurrent or Metastatic Disease

Interventions

cetuximab IV

Biopsies

Study Description

Brief 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.