Identification of a Gene Expression Signature Profile for Panitumumab Sensitivity in Untreated Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)

Inclusion Criteria:

1. Untreated, suspected or histologically documented locally advanced clinical stage III
or IVa-b(M0)SCCHN, no evidence of distant metastases. Prior surgery with diagnosis of
SCCHN acceptable

2. Candidate for definitive surgery or radiation based therapy.

3. Fresh frozen tumor tissue must be available for genomic analysis and must pass RNA
Quality Control prior to research PET/CT #1 and/or initiating panitumumab

4. Measurable or evaluable disease

5. ECOG 0-1

6. ≥18 years of age

7. Adequate organ function

1. neutrophil count (ANC or AGC) ≥1.5 x 109/L

2. Platelet count ≥75 x 109/L

3. Hemoglobin ≥9.0 g/dL

4. Creatinine ≤1.5x ULN

5. Hepatic enzymes (AST, ALT)≤2.5x ULN, Total Bilirubin <1.5x ULN

6. Magnesium ≥ LLN

8. Negative serum pregnancy test ≤7 days before starting panitumumab (for women of
childbearing potential only)

9. Competent to comprehend, sign, and date a written informed consent form

10. Sexually active males & females of reproductive potential must agree to use adequate
method of contraception during treatment & for 6 months after study drug stopped

Exclusion Criteria:

1. History of other malignancy within past 2 years, except:

1. Malignancy treated with curative intent and with no known active disease

2. Adequately treated non-melanomatous skin cancer or lentigo maligna with no
evidence of disease

3. Adequately treated cervical carcinoma in situ with no evidence of disease

4. Prostatic intraepithelial neoplasia with no evidence of prostate cancer

2. Primary tumor of the nasopharynx (nasopharyngeal cancer), sinuses, salivary gland, or
skin. (Squamous cell carcinoma arising in/near nasopharynx is eligible)

3. Prior radiotherapy in planned field if it prevents standard radiotherapy dose and
field

4. Prior radiation for head & neck cancer

5. Prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule
EGFR inhibitors (e.g., gefitinib, erlotinib, lapatinib)

6. Prior anti-cancer treatment with: chemotherapy, hormonal therapy, immunotherapy,
experimental or approved proteins/antibodies within the past 5 years.

7. Prior systemic chemotherapy for study cancer

8. Investigational agent or therapy ≤30 days before enrollment and/or have not recovered
from such side effects

9. Continued chronic use of immunosuppressive agents during the clinical trial period
(e.g., methotrexate and cyclosporine), corticosteroids are allowed

10. Clinically significant cardiovascular disease (including MI, unstable angina,
symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤6
months before enrollment

11. History of interstitial lung disease e.g., pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest CT scan. Patients with CT
scan findings consistent with lung scarring from COPD or previous infection are
eligible

12. History of any medical or psychiatric condition or laboratory abnormality that in the
opinion of the investigator may increase the risk associated with the study
participation or investigational product(s) administration or may interfere with the
interpretation of the results

13. Unwilling or unable to comply with study requirements

14. Pregnant or breast feeding, or planning to become pregnant within 6 months after the
end of treatment

15. Known positive test(s) for HIV infection

16. Major surgery within 2 weeks of enrollment. Staging endoscopy with
biopsy/tonsillectomy for head & neck cancer, tracheostomy, and/or gastrostomy tube
placement eligible one day after procedure. May consent to tissue collection biopsy
pre-endoscopy/minor surgery and then begin protocol therapy one day after procedure.

17. Known allergy/hypersensitivity to any component of the study treatment(s)

18. Infection requiring intravenous antibiotics for any uncontrolled infection ≤14 days
prior to enrollment

19. Subjects on anticoagulant therapy. Aspirin and other anti-platelet agents will not be
defined as anticoagulant therapy for this study