NCT01289522

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Head and Neck Carcinoma
• Recurrent or Metastatic Disease

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab IV	* 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.
OTHER	Biopsies	No intervention, only biopsy for translational project.

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-02-03
• Last updated: 2017-05-15
• Results posted: 2017-04-07

Locations

14 sites across 2 countries: Belgium, France