Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
SCC Head and Neck Cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cetuximab Type: Drug
Name: 50-60 Gy and 70 Gy Type: Radiation
Overall Status
Recruiting
Summary
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.
Locations
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Shruti Jolly, M.D. - 734-936-4302 - shrutij@umich.edu
University of Michigan Veterans Administration Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Shruti Jolly, M.D. - 734-936-4302 - shrutij@umich.edu
Start Date
February 2009
Completion Date
February 2016
Sponsors
University of Michigan Cancer Center
Source
University of Michigan Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page