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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


Phase 2
70 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

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