Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
SCC Head and Neck Cancer
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Cetuximab Type: Drug
Name: 50-60 Gy and 70 Gy Type: Radiation
Overall Status
This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.
Detailed Description
Primary Objective 1: Determine changes in tumor EGFR, pEGFR, downstream signaling and novel phosphoproteins following a loading dose of cetuximab in patients who are poor candidates for chemoradiation (age =70 years or with significant co-morbidities) and are therefore treated with cetuximab with radiation.

Primary Objective 2: Characterize clinical outcomes, including local recurrence, progression-free survival and overall survival in these patients, and correlate these clinical outcomes with the changes in tumor EGFR, pEGFR, downstream signaling, and novel phosphoproteins.

Primary Objective 3: Describe the toxicity, in particular mucositis/dysphagia, of this regimen.

Secondary Objective 1: Conduct normal mucosa EGFR assessment for comparison with tumor sample.

Secondary Objective 2: Correlate HPV presence and titer with p53 status and clinical outcome.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 70 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients must have pathologically-confirmed, previously untreated, clinically accessible (without general anesthesia) locally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or nonresectable head and neck squamous cell carcinomas of the skin.

- Patients will be limited to:

- ≥ 70 years of age, OR

- with co-morbidities that preclude treatment with standard platinum-based chemotherapy, as determined by the treating physician, OR

- KPS ≤ 80, OR

- Creatinine clearance < 30 cc/min

- Laboratory criteria:

- WBC > 3500/ul

- Granulocyte > 1500/ul

- Platelet count > 100,000/ul

- Total Bilirubin < 1.5 X ULN

- AST and ALT < 2.5 X ULN

- Patients must give documented informed consent to participate in this study.

Exclusion Criteria:

- Prior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer).

- Prior head and neck radiation or chemotherapy.

- Documented evidence of distant metastases.

- Patients with nasopharyngeal carcinoma.

- Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment.

- Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.

- Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule).

- Patients residing in prison.
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Shruti Jolly, M.D. - 734-936-4302 -
University of Michigan Veterans Administration Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Shruti Jolly, M.D. - 734-936-4302 -
Start Date
February 2009
Completion Date
February 2016
University of Michigan Cancer Center
University of Michigan Cancer Center
Record processing date processed this data on July 28, 2015 page