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
70 Years
N/A
Both
Head and Neck Cancer
Trial Information
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
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.
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.
- 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine changes in tumor EGFR, pEGFR, following a loading dose of cetuximab in patients who are poor candidates for chemoradiation .
Outcome Time Frame:
2 Years
Safety Issue:
No
Principal Investigator
Shruti Jolly, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Michigan Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
UMCC 2009.009
NCT ID:
NCT00904345
Start Date:
February 2009
Completion Date:
February 2015
Related Keywords:
- Head and Neck Cancer
- SCC Head and Neck Cancer
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| University of Michigan Medical Center | Ann Arbor, Michigan 48104-0914 |
| University of Michigan Veterans Administration Hospital | Ann Arbor, Michigan |
