Capecitabine For Nasopharyngeal Cancer
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|