Capecitabine For Nasopharyngeal Cancer
|ClinicalTrials.gov Identifier: NCT00095901|
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : March 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Capecitabine||Phase 2|
This is a nonrandomized, multicenter study.
- Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Capecitabine In Previously Treated, Recurrent And/Or Metastatic Nasopharyngeal Carcinoma|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
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.
Other Name: Xeloda
- Rate of Response [ Time Frame: 4 weeks ]Tumor response rate based on tumor measurement (according to the nasT criteria). Response Evaluation Criteria in Solid Tumors (RECIST).
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095901
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Lori J. Wirth, MD||Dana-Farber Cancer Institute|