Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer

Study Overview
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Brief Summary
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RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. 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 stereotactic body radiation therapy together with cetuximab may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.

Detailed Description
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OBJECTIVES: Primary To assess the toxicity of stereotactic body radiotherapy delivered concurrently with cetuximab in patients with recurrent squamous cell carcinoma of the head and neck. Secondary To assess the feasibility of delivering this regimen in these patients. To assess the impact of this regimen on local control, distant control, and overall survival of these patients. OUTLINE: Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5. Patients undergo 1 fraction of stereotactic-body radiotherapy (RT) in week 2. At 4 weeks after RT completion, patients may receive additional cetuximab IV combined with a 28-day chemotherapy regimen, per investigator discretion. After completion of study treatment, patients are followed every 2 months for 1 year, every 3-4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Official Title
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A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Biological: cetuximab
* Radiation: stereotactic body 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, paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx Medically or surgically inoperable disease or patient refuses surgery Recurrent disease Previously irradiated disease meeting the following criteria: Prior radiotherapy completed > 6 months from re-irradiation Prior radiotherapy in the region of the study cancer that would result in overlap of radiation therapy fields Majority of the recurrent tumor volume (> 50%) received prior radiotherapy dose of 30-75 Gy No distant metastatic disease PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 3 months Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 60 days after completion of study treatment No prior allergic reaction to study drugs PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior surgical resection of the recurrent primary tumor and/or regional lymphatics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetuximab<br>Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5 | Biological: cetuximab<br>* Given IV<br>Radiation: stereotactic body radiation therapy<br>* Undergoing Radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30 |  | Daily while on Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients |  | 2 years | 
| Local and Distant Control |  | very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter. | 
| Overall Survival |  | very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter | 

 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, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity