Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase I/II Study of Taxotere, Cisplatin, 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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