A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer

Inclusion Criteria:

- Age 18 years or older

- Histologically or cytologically confirmed diagnosis of squamous cell or poorly
differentiated carcinomas of the head and neck (excluding lip), or lymphoepithelioma

- No prior chemotherapy or radiotherapy

- Prior surgical therapy will consist only of incisional or excisional biopsy, and
organ sparing procedures such as debulking of airway-compromising tumors or neck
dissection in a patient with an existing primary tumor

- Karnofsky performance status of >= 70%

- Intact organ and bone marrow function

- Obtained informed consent

Exclusion Criteria:

- Demonstration of metastatic disease (i.e. M1 disease).

- Patients with a history of severe allergic reaction to docetaxel or other drugs
formulated with polysorbate 80. History of allergic reactions attributed to compounds
of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or
hydroxyurea

- Other coexisting malignancies or malignancies diagnosed within the previous 3 years
with the exception of basal cell carcinoma, cervical cancer in situ, and other
treated malignancies with no evidence of disease for at least 3 years.

- Prior surgical therapy other than incisional or excisional biopsy and organ-sparing
procedures such as debulking of airway-compromising tumors or neck dissection in a
patient with an unknown primary tumor. Any non-biopsy procedure must have taken place
less than 3 months from initiating protocol treatment.

- Incomplete healing from previous surgery

- Pregnancy or breast feeding (men and women of child-bearing potential are eligible
but must consent to using effective contraception during therapy and for at least 3
months after completing therapy)

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure (CHF), unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements

- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any
history of clinically significant CHF are excluded. The exclusion of patients with
active coronary artery disease will be at the discretion of the attending physician.

- Uncontrolled active infection unless curable with treatment of their cancer.