A Phase II Study Of Capecitabine In Previously Treated, Recurrent And/Or Metastatic Nasopharyngeal Carcinoma
OBJECTIVES:
Primary
- Determine the overall response rate (complete response and partial response) in
patients with previously treated recurrent locoregional or metastatic carcinoma of the
nasopharynx treated with capecitabine.
Secondary
- Determine median progression-free survival of patients treated with this drug.
- Determine median overall survival of patients treated with this drug.
- Correlate tissue thymidine phosphorylase (TP) levels with response to this drug in
these patients.
- Correlate the Epstein-Barr virus (EBV) status of these patients with response to this
drug.
- Correlate survival with the EBV status of patients treated with this drug.
- Correlate TP levels with EBV status of patients treated with this drug.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21
days.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response as assessed by RECIST criteria
No
Lori J. Wirth, MD
Study Chair
Dana-Farber Cancer Institute
United States: Federal Government
CDR0000393550
NCT00095901
June 2004
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |