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

Not Applicable

Terminated

• Conditions: Head and Neck Cancer
• Interventions: Biological: cetuximab; Radiation: stereotactic body radiation therapy

• Registration Number: NCT00891904
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2011-07
• Results First Submitted: 2014-01-29
• Results First Submitted QC: 2014-01-29
• Results First Posted: 2014-03-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cetuximab	cetuximab	Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
Cetuximab	stereotactic body radiation therapy	Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5

Primary Outcome Measures

Name	Time	Method
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30	Daily while on Treatment

Secondary Outcome Measures

Name	Time	Method
Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients	2 years
Local and Distant Control	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	very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States