Cetuximab and Stereotactic Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

Sponsor

Centre Oscar Lambret (Other)

Overall Status

Completed

CT.gov ID

NCT00738868

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving cetuximab together with stereotactic radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how giving cetuximab together with stereotactic radiation therapy works in treating patients with recurrent squamous cell carcinoma of the head and neck cancer that cannot be removed by surgery.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Biological: cetuximab Radiation: stereotactic body radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

Primary

Evaluate local control at 12 months in patients with recurrent squamous cell carcinoma of the head and neck treated with cetuximab and stereotactic radiotherapy.

Secondary

Determine the incidence of cutaneous toxicity.
Assess the care and development of skin reactions.
Determine the quality of life of patients treated with this drug.
Determine tumor response at 2 months.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV once weekly for 5 weeks. Patients undergo stereotactic radiotherapy 3 times weekly during weeks 2 and 3.

After completion of study therapy, patients are followed at 2 months and then every 3 months for 2 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Non-Randomized

Primary Purpose:

Treatment

Official Title:

Re-irradiation and Stereotactic Cetuximab in Patients With Recurrent Carcinoma of the Head and Neck

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma of the head and neck
Unresectable disease
Recurrent disease
No metastatic disease
Disease in previously irradiated area must be proven by biopsy or imaging
At least 3 months between prior radiotherapy and diagnosis of recurrent disease
Surgery or brachytherapy must be possible
Measurable or evaluable disease by RECIST criteria
No available curative therapy

PATIENT CHARACTERISTICS:

Karnofsky performance status 60-100%
Not pregnant or nursing
No psychological, familial, social, or geographical reasons that would make monitoring the patient impossible
No other malignant disease