Phase I Study of Weekly Nanoparticle Albumin-Bound Paclitaxel (Abraxane) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients With Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC)

Inclusion Criteria:

- Locally and/or regionally advanced head and neck squamous cell carcinoma (AJCC Stage
III-IVB)

- Karnofsky performance status ≥ or = to 70%

- Adequate bone marrow function: absolute neutrophil count ≥ or = to 1,500/μl,
platelets ≥ or = to 100,000/μl, hemoglobin ≥ or = to 9 gm/dl

- Adequate hepatic function:

Total Bilirubin ≤ or = to institutional upper limit of normal (ULN) AST and ALT and
Alkaline Phosphatase must be within the range allowing for eligibility. In determining
eligibility the more abnormal of the two values (AST or ALT) should be used

- Patients must have adequate renal function: serum creatinine ≤ 1.5 mg/dl or estimated
creatinine clearance of ≥ 45 ml/min by Cockcroft and Gault method

- Men and women of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter

- Women of childbearing potential must have a negative pregnancy test

- Patients must have ability to understand and the willingness to sign a written
informed consent document

Exclusion Criteria:

- Other active malignancy, other than indolent malignancies which the investigator
determines are unlikely to interfere with treatment or efficacy analysis. For
example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or
prostate cancer within the no current biochemical (PSA) or radiologic evidence of
disease may enroll

- Prior radiation therapy for head and neck cancer

- Patients with multifocal peripheral sensory alterations or paresthesias (including
tingling) interfering with function, per patient report (example: activities of daily
living)

- Inability to comply with study and/or follow-up procedures

- Women who are pregnant or lactating

- Serious concomitant medical disorders (for example, active infection, uncontrolled
seizure disorder, unstable angina, auto-immune connective tissue disease) that, in
the opinion of the investigator, would compromise the safety of the patient or
compromise the patient's ability to complete the study

- History of severe infusion reaction to a monoclonal antibody

- Patients with nasopharyngeal carcinoma are not eligible