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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738868
• Other study ID #: CDR0000589673
• Secondary ID: COL-CKNO-RERTCOL
• Status: Completed
• Phase: Phase 2
• First received: August 20, 2008
• Last updated: May 12, 2011
• Start date: October 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Biological:
• cetuximab

Radiation:
• stereotactic body radiation therapy

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria			No