TPLF-4, Compressed TPLF for Locally Advanced Squamous Cell Carcinoma
- 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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the safety of a four day regimen of taxotere, cisplatin, 5-fluorouracil and high-dose leucovorin with growth factor support and ciprofloxacin.
Marshall Posner, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|