Clinical trial NCT00891904: Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2009-05-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
timeFrame: Daily while on Treatment
Secondary outcomes:
measure: Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients
timeFrame: 2 years
measure: Local and Distant Control
timeFrame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.
measure: Overall Survival
timeFrame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Anurag K. Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: