Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

David A. Clump, MD, PhD

Status and phase

Completed

Phase 2

Conditions

Squamous Cell Carcinoma of the Head and Neck

Treatments

Device: Stereotactic radiosurgery

Drug: Cetuximab

Study type

Interventional

Funder types

Other

Identifiers

NCT01104922

UPCI 06-093

Details and patient eligibility

About

This trial examines survival and toxicity in previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities associated with the above therapy.

Full description

Squamous cell carcinoma of the head and neck is the sixth most common malignancy worldwide with approximately 500,000 cases worldwide yearly. There were an estimated 39,250 new cases and 11,000 deaths in the United States in 2005 (Jemal 2005, Spitz MR). Despite major improvements in the treatment of SCCHN in recent years which include the introduction of concurrent chemoradiotherapy as an effective primary or postoperative therapy, the five-year survival rate for patients with SCCHN in the United States and other developed countries remains poor as nearly 50-60% of these patients will die as a direct result of recurrent locoregional disease. This study aims to determine the 1-year progression-free survival (PFS) of previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities associated with the therapy.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically proven recurrent squamous cell carcinoma of the head and neck (SCCHN), who has received prior radiotherapy with or without chemotherapy. New primary is allowed if location is in a previously irradiated field. Biopsy is recommended for each recurrence; but is not mandated per study. This will be at the discretion of the principal investigator.
Prior radiation dose of at least 60 Gy.
Disease confined to locoregional site and can be encompassed in a stereotactic radiosurgery "portal"
Tumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria. These criteria include encasement of great vessels, vertebral invasion or undue peri-operative risk.
Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients. A minimum of 4 weeks should elapse between any surgery and treatment on study. However, high risk pathologic features should be present, such as positive margins, positive lymphadenopathy, perineural or angiolymphatic invasion. Measurable disease must be present for assessment of response.
Karnofsky performance status > 60 (ECOG 0-2)
Prior treatment with an EGFR Inhibitor is allowed if it was a part of prior curative therapy and was completed at least 30 days prior to commencement of study therapy
Any number of prior chemotherapy regimens are allowed
Measurable disease on imaging studies (MRI, CT, PET-CT or physical exam)
Age > 18
Estimated life expectancy > 12 weeks
No prior radiation therapy or chemotherapy within 1 month of study enrollment
No prior chemotherapy or targeted therapy within the previous 4 weeks
ANC > 1000, PLT>75,000, Serum creatinine<2.5 mg/dL, Bilirubin <1.5 x upper limits of normal (ULN)
Diabetes must be controlled prior to PET-CT scanning (blood glucose <200 mg/dL)
Ability to provide written informed consent

Exclusion criteria

Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
History of any cancer other than SCCHN (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years.
Patients in their reproductive age group should use an effective method of birth control. Patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study
Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
Concurrent serious infection
History of known hypersensitivity to cetuximab or similar agents