Capecitabine For Nasopharyngeal Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: Capecitabine

• 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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted QC: 2004-11-08
• Study First Submitted: 2004-11-09
• Study First Posted: 2004-11-09
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

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 EBV status to thymidine phosphorylase expression as assessed by Fischer's exact test	Basleine 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

Trial Locations

Locations (3)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States