Chemotherapy, Radiation Therapy, and Cetuximab in Treating Patients With the Head and Neck Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with radiation therapy and cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation therapy and cetuximab works in treating patients with head and neck cancer.

Detailed Description
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OBJECTIVES: Primary Evaluate disease-free survival at 2 years in patients with poor prognosis squamous cell carcinoma of the head and neck treated with chemoradiotherapy and cetuximab after complete surgical resection. Secondary Evaluate quality of life. Evaluate tolerability. Evaluate overall survival. Analyze germinal polymorphisms. OUTLINE: This is a multicenter study. Patients receive cetuximab IV on day 1. Treatment with cetuximab repeats every week for up to 8 courses. Patients also receive cisplatin IV on day 8. Treatment with cisplatin repeats every 3 weeks for up to 3 courses. Patients undergo concurrent radiotherapy 5 times a week for 7 weeks beginning on day 8. After completion of study treatment, patients are followed at 1 month and then every 3 months for 2 years.

Official Title
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Phase II Study Evaluating Radiotherapy-chemotherapy and Cetuximab in Patients With Histologically Proven Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx and With a Poor Prognosis After Complete Surgical Resection

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Biological: cetuximab
* Drug: cisplatin
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx Must have undergone complete macroscopic resection Presence of ≥ 1 of the following poor prognostic factors after complete resection: Incomplete microscopic resection and N+ Complete microscopic resection and > 2 N+ Vascular and/or lymphatic embolism At least 2 peripheral nerve invasions Positive surgical margins and pT4 lesion No metastases PATIENT CHARACTERISTICS: WHO performance status 0-2 ANC > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 9 g/dL Bilirubin < 1.5 times upper limit of normal (ULN) Serum creatinine < 1.25 times ULN and/or creatinine clearance > 55 mL/min Not pregnant or nursing Fertile patients must use effective contraception No serious and disabling cardiac, renal, hepatic, or respiratory failure No coronary artery disease or myocardial infarction within the past year No uncontrolled cardiac arrhythmia Other active and serious diseases allowed at discretion of the investigator No known severe allergy to cisplatin, cetuximab, or any of their excipients No other malignant disease diagnosed within the past 5 years except for basal cell carcinoma of the skin or in situ cervical cancer No psychological, familial, social, or geographic situations that preclude clinical follow up PRIOR CONCURRENT THERAPY: No prior treatment (except surgery) for this cancer or another head and neck cancer At least 3 months since prior treatment with an investigational agent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetuximab<br> | Biological: cetuximab<br> <br> Drug: cisplatin<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival at 2 years |  | 2 YEARS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, tongue cancer