Status:
TERMINATED
Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief 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 to...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00904345
Start Date
April 1 2009
End Date
December 1 2020
Last Update
February 24 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
2
University of Michigan Veterans Administration Hospital
Ann Arbor, Michigan, United States, 48109