Head and Neck Cancer
Conditions
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
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.
Interventions
BIOLOGICALcetuximab
Given IV
RADIATIONstereotactic body radiation therapy
Undergoing Radiotherapy
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30 | Daily while on Treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biological/Vaccine: Cetuximab All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2). | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Biological/Vaccine: Cetuximab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 2.8 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 2 / 2 |
Outcome results
Primary
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
Time frame: Daily while on Treatment
Population: Trial terminated early. Too few patients to analyze.
Secondary
Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients
Time frame: 2 years
Population: Trial terminated early. Too few patients to analyze.
Secondary
Local and Distant Control
Time frame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.
Population: Trial terminated early. Too few patients to analyze.
Secondary
Overall Survival
Time frame: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter
Population: Trial terminated early. Too few patients to analyze.