A Phase II Trial of Docetaxel, Cisplatin, 5-FU, and Leucovorin for Carcinoma of the Nasopharnyx
OBJECTIVES: I. Determine the complete and overall response rate to docetaxel, cisplatin,
fluorouracil, and leucovorin calcium in patients with potentially curable nasopharyngeal
cancer. II. Assess the tolerability of this regimen in these patients.
OUTLINE: Patients receive docetaxel IV over 1 hour followed 1 hour later by cisplatin IV
over 4 hours and fluorouracil IV and leucovorin calcium IV over 96 hours. Filgrastim (G-CSF)
is administered subcutaneously beginning on day 5 and continuing until blood counts recover
or day 10. Treatment repeats every 3 weeks for up to 3 courses. Within 2 weeks after the
completion of chemotherapy, patients undergo definitive radiotherapy for about 7 weeks.
After radiotherapy, patients who did not achieve complete remission after chemotherapy may
undergo surgery. Patients are followed monthly for 1 year, then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Primary Purpose: Treatment
A. Dimitrios Colevas, MD
NCI - Investigational Drug Branch
United States: Federal Government
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|