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

Head and Neck Cancer Clinical Trial

Official title:

A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00891904
• Other study ID #: CDR0000640992
• Secondary ID: RPCI-I-143108
• Status: Terminated
• Phase: N/A
• First received: April 30, 2009
• Last updated: September 29, 2015
• Start date: April 2009

Study information

• Verified date: September 2015
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Biological:
• cetuximab
Given IV

Radiation:
• stereotactic body radiation therapy
Undergoing Radiotherapy

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30		Daily while on Treatment	Yes
Secondary	Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients		2 years	No
Secondary	Local and Distant Control		every 2 months for year one, every 3-4 months for year 2, every 6 months for	No
Secondary	Overall Survival		every 2 months for year one, every 3-4 months for year 2, every 6 months for	No