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

Roswell Park Comprehensive Cancer Center

Status: Terminated

Conditions: Head and Neck Cancer

Treatments: Radiation: stereotactic body radiation therapy; Biological: cetuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00891904

CDR0000640992

RPCI-I-143108

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Cetuximab

Experimental group

Description:

Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5

Treatment:

Biological: cetuximab

Radiation: stereotactic body radiation therapy