Phase I/II Pilot Study of Induction Chemotherapy With Docetaxel in Combination With Cisplatin and 5-Fluorouracil (5-FU) in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine whether cisplatin in combination with docetaxel and 5-fluorouracil can be given with acceptable side effects
Marshall Posner, MD
Dana-Farbar Cancer Institute
United States: Food and Drug Administration