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

Carcinoma of Head and/or Neck, Squamous Cell Carcinoma

squamous cell carcinoma, Taxotere, carcinoma of head/neck, Cisplatin, 5-Fluorouracil, Leucovorin

The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating 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.

No related papers found yet.

United States