Stereotactic Body Radiation Therapy (SBRT) With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Conditions
Recurrent - Head and Neck Cancer
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: SBRT Type: Radiation
Name: Cetuximab Type: Drug
Name: Docetaxel Type: Drug
Overall Status
Recruiting
Summary
Compare the overall survival of patients with the addition of docetaxel to the overall survival of patients treated with SBRT and cetuximab alone. In addition, we will determine the difference in progression free survival (PFS), the rate of local recurrence (LR) and of distant metastases (DM) across the SBRT and cetuximab + docetaxel arm and the arm receiving SBRT and cetuximab alone. To better resolve the impact of the experimental treatment on PFS, LR, and DM, patients will be stratified by the presence/absence of prior cetuximab treatment and then randomized to either the control arm (cetuximab and SBRT only) or the experimental arm (cetuximab, SBRT, and docetaxel).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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 50 Gy.

- Disease confined to locoregional site and can be encompassed in a stereotactic body 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.

- Karnofsky performance status > 60 (ECOG 0-1)

- 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

- 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

- 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, docetaxel or similar agents
Location
UPMC Shadyside Radiation Oncology
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Contact: Karen D Holeva, BS - 412-623-1275 - holevakd@upmc.edu
Start Date
May 2013
Sponsors
University of Pittsburgh
Source
University of Pittsburgh
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page