Correlative Study of Nicotine Levels With Response Rates to Therapy Using Radiation Alone or in Combination With Chemotherapy in Head and Neck Cancer

Inclusion Criteria:

- A: Male or female aged 18 or older

- B: Pathologically confirmed squamous cell carcinoma

- C: Measurable disease using CT, MRI, or panendoscopy

- D: Tumor sites to include:

Oropharynx Hypopharynx Oral cavity Larynx Measurable disease with no evidence of primary

- E: Patients to be treated with radiotherapy or chemoradiotherapy as a primary
treatment modality. Patients to be treated with radiotherapy in combination with
platinum based chemotherapy will be considered for enrollment.

- F: Nutritional status to include patients that do not require placement of a feeding
tube as well as patients that are feeding tube dependent. However, patients requiring
total parenteral nutrition prior to initiation of treatment will be excluded.

- G: ECOG performance status of 0, 1 or 2.

- H: Standard of care chemotherapy inclusion criteria to include:

i: No evidence of active angina pectoris or ventricular arrhythmia's; no myocardial
infarction within the last six months. (Patients with medically controlled
hypertension or congestive heart failure are eligible.) ii: Absolute neutrophil count
of > 1000/uL and platelet count > 100,000/uL iii: Serum total bilirubin < 1.5 mg/dL
iv: Creatinine Clearance greater than 60 ml/min creatinine clearance to be calculated
using the formula: (140 - age) x (wgt in kg) * (serum creatinine) x (72)

* multiply by 0.85 for females v: If a pre-existing grade I neuropathy exists,
patients must be willing to risk worsening neuropathy secondary to treatment.
Patients with grade II or greater neuropathy will be excluded from study.

- I: Standard of care treatment will require counseling against the use of tobacco
products and can include nicotine replacement at the request of the patient and
discretion of treating physician. Patients who continue to use tobacco products as
well as patients using any form of cessation strategy (nicotine replacement,
bupropion, or other) will be eligible for enrollment.

- J: Patients enrolled on experimental studies will be considered for enrollment with
final selection to be made by Dr. Kudrimoti, Dr. Warren, Dr. Arnold, and Dr.
Valentino.

- K: Ability to give informed consent

Exclusion Criteria:

- A: Pregnant females. Males and females of childbearing potential must use effective
contraception in order to prevent pregnancy during therapy.

- B: Histology other than squamous cell carcinoma

- C: Patients without measurable disease using CT, MRI, or panendoscopy

- D: Patients eligible for surgical resection alone or with significant (> 25%)
surgical tumor debulking prior to radiotherapy will not be considered for enrollment.
Furthermore, patients who are otherwise not candidates for radiotherapy at the
discretion of the treating physician will be excluded from enrollment.

- E: Patients with a history of previous or current malignancy at other sites diagnosed
within the last 5 years, with the exception of adequately treated carcinoma in-situ
of the cervix or basal or squamous cell carcinoma of the skin. Patients with a
history of other malignancies, who remain free of recurrence or metastases for
greater than five years are eligible.

- F: Patients with active infection will not be eligible for this protocol until the
infection is treated and the symptoms have clinically resolved.

- G: Prior chemotherapy, prior irradiation or surgery for SCCHN will not be allowed.

- H: Patients with metastatic disease will not be eligible for this study.

- I: Patients with grade II or greater peripheral neuropathy will be excluded from
study.

- J: Patients receiving medication to prevent mucositis (palifermin, amifostine, or
other).

- K: Patients requiring total parenteral nutritional support prior to the initiation of
treatment will not be eligible for study.