A Phase I/II 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.
Marshall Posner, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|