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