Radiation With Cetuximab in Head and Neck Squamous Cell Carcinoma Who Do Not Qualify For Chemotherapy



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:70 - Any
Updated:10/2/2013
Start Date:April 2009
End Date:December 2019
Contact:Cancer AnswerLine
Phone:1-800-865-1125

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase II Study of Radiation Therapy Concurrent With Cetuximab in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Do Not Qualify For Standard Chemotherapy Due To Age>70 Or Co-Morbidities


The PI proposes to select locally advanced head and neck cancer patients, who are older than
age 70 or are not deemed candidates for chemotherapy, to determine changes in tumor
Epidermal Growth Factor Receptor (EGFR), Phosphorylated Epidermal Growth Factor Receptor
(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 and radiation.

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. Describe the
toxicity, in particular mucositis/dysphagia, of this regimen.


Inclusion Criteria:

- Patients must have pathologically-confirmed, previously untreated, clinically
accessible (without general anesthesia) locally advanced squamous cell carcinoma of
the larynx, hypopharynx, oropharynx, or oral cavity. The patients will be limited to
age 70 and older, OR with co-morbidities that preclude treatment with standard
platinum-based chemotherapy, as determined by the treating physician, OR KPS of at
least 80, OR Creatinine clearance less than 30cc/min.

Exclusion Criteria:

- younger than age 70
We found this trial at
1
site
University of Michigan Comprehensive Cancer Center
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
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