Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

• Treatment begins with a one hour infusion of docetaxel followed by a 1/2 hour infusion of cisplatin. 5-fluorouracil will be administered through continuous IV infusion through a portable pump for four days at home. A cycle is twenty-one days long ( 4 days of chemotherapy and 17 days of recovery).
• During each cycle blood tests will be performed weekly. A physical exam will be performed and the impact of the chemotherapy will be assessed at the end of each cycle.
• If after 2 cycles the patients cancer has not responded sufficiently they will be removed from the study.
• If significant reduction in the size of the tumor is observed after cycle 2, a third and final cycle will be performed. Followed by radiation therapy twice daily for approximately 6-7 weeks.

Inclusion criteria

• Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of head and neck (SSCHN).
• At least one bi- or uni-dimensionally measurable lesion.
• Stage II or IV disease without evidence of distant metastasis.
• No previous chemotherapy, radiotherapy or surgery (other than biopsy) for SSCHN.
• Age greater than 18 years.
• ECOG performance status of 0 or 1.
• Life expectancy of greater than 12 weeks.
• Adequate bone marrow, hepatic and renal function.
• Normal serum calcium

Exclusion criteria

• Primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands.
• Patients with any non-SSCHN malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix.
• Any prior treatment with chemotherapy.
• Prior radiotherapy to major bone marrow area (> 10% bone marrow) or to head and neck.
• Current peripheral neuropathy of greater than NCI grade 2.
• Other serious illness or medical condition
• Concurrent treatment with corticosteroids unless chronic treatment at low doses.
• Pregnant or lactating females or females of childbearing potential not employing adequate contraception.