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

Centre Oscar Lambret

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00738868

INCA-RECF0629

CDR0000589673

COL-CKNO-RERT

COL-0705

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No concurrent participation in another clinical study of an experimental drug