Squamous Cell Carcinoma Clinical Trial
Official title:
TPLF-4, Compressed TPLF for Locally Advanced Squamous Cell Carcinoma
The purpose of this study is to further test a combination chemotherapy regimen for the treatment of squamous cell carcinoma of the head and neck and to see if the addition of supportive medicine can help reduce the side effects of these drugs.
- Patients will be admitted to hospital and receive a one hour infusion of taxotere.
Approximately 2 hours after taxotere is finished they will receive cisplatin,
5-fluorouracil, and leucovorin continuously over a 4 day period.
- Approximately 6-12 hours after the chemotherapy ends patients will be given growth
factor support and ciprofloxacin until the patient's ANC level is greater than 10,000.
- Infusion of chemotherapy will be repeated every 28 days (1 cycle is 28 days).
- During each cycle patients will have blood tests performed weekly and may be asked to
return to the Head and Neck Clinic for examination around the middle of each cycle.
- At the end of each cycle the impact of the chemotherapy will be assessed. If after 2
cycles, the cancer has not responded sufficiently the patient will not receive any more
chemotherapy. However, if significant reduction in the size of the patients tumor is
observed, a third and final cycle will be performed.
- During the fourth or fifth week of cycle 3, patients will undergo re-staging evaluation
under anesthesia with primary-site biopsies and planning of radiotherapy.
- Within 2 weeks of completion of chemotherapy cycle 3 all patients will receive twice
daily radiotherapy.
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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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