This randomized phase II trial studies how well stereotactic radiosurgery and cetuximab with docetaxel work compared with stereotactic radiosurgery and cetuximab alone in treating patients with head and neck cancer previously treated with radiation therapy that has come back after a period of improvement (recurrent). Stereotactic radiosurgery, also called stereotactic body radiation therapy (SBRT), uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving stereotactic radiosurgery and cetuximab with or without docetaxel is more effective in killing tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02057107.
PRIMARY OBJECTIVES:
I. To determine the 1-year locoregional progression-free survival (PFS) of previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with SBRT (stereotactic radiosurgery) and cetuximab and docetaxel.
II. To evaluate the acute and late toxicities associated with the above therapy.
SECONDARY OBJECTIVES:
I. To evaluate the impact of adjuvant docetaxel and cetuximab on incidence of distant disease.
II. To determine the objective response rate, PFS, and overall survival (OS) of the novel regimen.
III. To evaluate the impact of docetaxel on response rates with SBRT.
IV. To assess the toxicity of combination docetaxel-cetuximab and SBRT.
V. To evaluate changes in tumor glucose metabolism post-therapy as assessed by fludeoxyglucose F 18 (FDG)-positron emission tomography (PET).
VI. To evaluate the expression of tumor-specific biomarkers before and after treatment.
VII. To evaluate the impact of study interventions on patient-reported quality of life (PR-QOL).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cetuximab intravenously (IV) over 120 minutes on day -7 one week prior to stereotactic radiosurgery (SRS). Patients undergo SRS for a total of 5 fractions and receive concurrent cetuximab IV over 60 minutes and docetaxel IV over 60 minutes on days 0 and 8. Patients then receive cetuximab IV over 60 minutes and docetaxel IV over 60 minutes weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive cetuximab IV over 120 minutes on day -7 one week prior to SRS. Patients then undergo SRS and receive concurrent cetuximab as in Arm I. Patients then receive cetuximab IV over 60 minutes weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6-8 weeks and then every 3 months for 16 months.
Lead OrganizationUPMC-Shadyside Hospital
Principal InvestigatorDavid Anthony Clump
