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

N/ATerminatedNCT00891904

Roswell Park Cancer Institute2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30

Time frame: Daily while on Treatment

Secondary Outcomes

Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients

Time frame: 2 years

Local and Distant Control

Time frame: 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

Time frame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter