Overview

This trial is active, not recruiting.

Condition squamous cell carcinoma of the head and neck
Treatment cetuximab and stereotactic radiosurgery
Phase phase 2
Target EGFR
Sponsor University of Pittsburgh
Start date July 2007
End date December 2016
Trial size 59 participants
Trial identifier NCT01104922, UPCI 06-093

Summary

The primary objectives of this study are 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 above therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
To determine the 1-year progression-free survival (PFS) of previously irradiated patients with SCCHN treated with radiosurgery and cetuximab;
time frame: 3 years

Secondary Outcomes

Measure
To evaluate the acute and late toxicities associated with the above therapy.
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
Principal investigator Dwight Heron, FACP, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Pittsburgh.