Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 70 - Any |
| Updated: | 2/9/2019 |
| Start Date: | April 2009 |
| End Date: | December 2019 |
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
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.
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.
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.
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, 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.
We found this trial at
2
sites
Ann Arbor, Michigan
Principal Investigator: Shruti Jolly, M.D.
Phone: 734-936-4302
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