Squamous Cell Carcinoma of Head and Neck Clinical Trial
Official title:
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)
The purpose of this study is to determine the appropriate dose, that dose which is found to give maximum effect with limited toxicity, of cisplatin in combination with docetaxel and 5-fluorouracil and then to further define the safety and effectiveness of this combination of medications.
- 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
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