Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel,
cisplatinum, and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity
to determine what effects these agents may have on cancer cells.

Approximately 60 patients will take part at multi-sites with potentially 20 patients
participating at the Emory Winship Cancer Institute in Atlanta, Georgia.

Inclusion Criteria:

- Histologically or cytologically proven squamous cell carcinoma of the oral cavity.

- Primary tumor sites eligible: oral cavity. Although they are admittedly of squamous
cell types, the following tumors will be excluded because their responsiveness to
chemotherapy may differ: tumors of the nasal and paranasal cavities and of the
nasopharynx. Oral cavity tumors with mandible invasion are excluded because the tumor
biology and management of these tumors is more complex and will likely include upfront
surgical resection.

- Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray,
abdominal ultrasound, or CT scan (liver function test abnormalities); bone scan in
case of local symptoms.

- At least one uni- or bi-dimensionally measurable lesion.

- Age ≥ 18 years.

- World Health Organization (WHO) performance status of 2 or less.

- No active alcohol addiction.

- Final eligibility for a clinical trial is determined by the health professionals
conducting the trial.

Exclusion Criteria:

- Pregnant or breast feeding

- Previous malignancies at other sites, with the exception of adequately treated in situ
carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other
cancer curatively treated by surgery and with no evidence of disease for at least 5
years.

- Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.

- Patients who experience an involuntary weight loss of more than 25% of their body
weight in the 2 months preceding study entry.

- Concurrent treatment with any other anti-cancer therapy.

- Participation in an investigational trial within 30 days of study entry.

- Patients with a history of severe hypersensitivity reaction to Taxotere® or other
drugs formulated with polysorbate 80.

- No previous chemotherapy or radiotherapy for any reason and no previous surgery for
SCCHN [squamous cell carcinoma of the head and neck] (other than biopsy) are allowed
at the time of study entry.

- Final eligibility for a clinical trial is determined by the health professionals
conducting the trial.