Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck

• Patients will be premedicated at home with dexamethasone and leucovorin.
• On the first day of treatment, the patient will receive taxotere intravenously for one hour. Approximately one hour after the taxotere is completed, the patient will receive a 4 hour infusion of cisplatin and begin a four day continuous infusion of 5-fluorouracil and leucovorin. The infusion of 5-fluorouracil and leucovorin will be completed at home with the use of an infusion pump. This process will be repeated every 21-35 days (1 cycle) depending upon how quickly the patient recovers from the chemotherapy.
• During each cycle blood tests will be performed weekly. During the first cycle a physical exam will be performed weekly and then halfway through each subsequent cycle and immediately prior to the start of each subsequent cycle.
• At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles the cancer has not responded the treatment will end. If significant reduction in the size of the tumor is observed, a third and final cycle will be done.
• After the last cycle of chemotherapy is done, radiation therapy will be performed twice daily for 6-7 weeks.

Inclusion criteria

• Histologic documentation of squamous cell carcinoma of head and neck
• Patients will previously untreated stage III or IV squamous cell carcinoma.
• Patients with locally recurrent disease after surgery.
• Life expectancy of longer than 3 months.
• Kidney function: 1.5 or a 24 hour creatinine clearance of > 30ml/min
• Liver function: SGOT < 1.5 X upper normal limit and alkaline phosphatase of < 2.5 X upper normal limit.
• WBC greater than or equal to 4,000/mm
• Platelet count greater than or equal to 100,000/mm
• Hemoglobin greater than or equal to 10gm/dl
• Patients of child-bearing age must use effective methods of contraception.

Exclusion criteria

• Patients treated with previous chemotherapy or radiotherapy for head and neck cancer.
• Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix.
• Pregnant or breast-feeding women