Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)
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.
Head and Neck Cancer
Radiation: 50-60 Gy and 70 Gy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of RT Concurrent w/ Cetuximab in Patients w/ Locally Advanced Head & Neck SCC Who Do Not Qualify For Standard Chemotherapy Due To Age >70 Or Co-Morbidities|
- Determine changes in tumor EGFR, pEGFR, following a loading dose of cetuximab in patients who are poor candidates for chemoradiation . [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Conduct normal mucosa EGFR assessment for comparison w/ tumor sample. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Correlate HPV presence & titer w/ p53 status & clinical outcome. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
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.
|Contact: Cancer AnswerLine||1-800-865-1125|
|United States, Michigan|
|University of Michigan Veterans Administration Hospital||Recruiting|
|Ann Arbor, Michigan, United States|
|Contact: Shruti Jolly, M.D. 734-936-4302 email@example.com|
|Principal Investigator: Shruti Jolly, M.D.|
|University of Michigan Medical Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109-0010|
|Contact: Shruti Jolly, M.D. 734-936-4302 firstname.lastname@example.org|
|Principal Investigator:||Shruti Jolly, MD||University of Michigan Cancer Center|