This study plans to examine the effects of Capecitabine administered as an oral chemotherapy drug in participants with nasopharyngeal cancer. Capecitabine is an oral prodrug. A "prodrug" is a drug that is converted within the body into its active form that has medical effects. Capecitabine is a prodrug of 5-fluorouracil (5-FU), which is a chemotherapy agent frequently used to treat head and neck cancers. Capecitabine is absorbed through the gastrointestinal tract and is converted to 5-FU. Capecitabine (Xeloda9) has been tested in subjects with colorectal and breast cancers, and shown to be effective in those cancers. Likewise, 5-FU has shown benefit when administered as a continuous infusion for those with nasopharyngeal cancers. Since Capecitabine is a prodrug of 5-FU, it is possible that similar results will be achieved. RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have locally recurrent or metastatic nasopharyngeal cancer.
This is a nonrandomized, multicenter study. \- Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Rate of Response
Tumor response rate based on tumor measurement (according to the nasT criteria). Response Evaluation Criteria in Solid Tumors (RECIST).
Time frame: 4 weeks
Correlation of Epstein-Barr virus (EBV) with response as assessed by a two-sample t-test with arcsin approximation
Time frame: Baseline and every 2 cycles
Correlation of EBV status to thymidine phosphorylase expression as assessed by Fischer's exact test
Time frame: Basleine and every 2 cycles
Correlation of response to thymidine phosphorylase expression as assessed by Fischer's exact test
Time frame: Baseline and every 2 cycles
Rate of Progression Free Survival
Time frame: Study Day 1 to the date of first known disease progression, or the date of death if the patient
Rate of Overall Survival
Time frame: Study Day 1 to the date of death or the last date patient was known to be alive
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