Capecitabine For Nasopharyngeal Cancer
- Registration Number
- NCT00095901
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
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.
- Detailed Description
This is a nonrandomized, multicenter study.
- Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Capecitabine Capecitabine Capecitabine (Xeloda 4:14. ) 150 mg and 500 mg tablets. Capecitabine will be administered at a dose of 1000 mg/m2 twice daily, for a total daily dose of 2000 mg/m 2. Capecitabine will administered P.O. or per G-tube B.I.D. for 14 days, followed by a one-week rest period in 3-week cycles.
- Primary Outcome Measures
Name Time Method Rate of Response 4 weeks Tumor response rate based on tumor measurement (according to the nasT criteria). Response Evaluation Criteria in Solid Tumors (RECIST).
- Secondary Outcome Measures
Name Time Method Correlation of Epstein-Barr virus (EBV) with response as assessed by a two-sample t-test with arcsin approximation Baseline and every 2 cycles Correlation of response to thymidine phosphorylase expression as assessed by Fischer's exact test Baseline and every 2 cycles Rate of Progression Free Survival Study Day 1 to the date of first known disease progression, or the date of death if the patient Rate of Overall Survival Study Day 1 to the date of death or the last date patient was known to be alive Correlation of EBV status to thymidine phosphorylase expression as assessed by Fischer's exact test Basleine and every 2 cycles
Trial Locations
- Locations (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
University of Chicago Cancer Research Center🇺🇸Chicago, Illinois, United States