Capecitabine in Treating Patients With Locally Recurrent or Metastatic Nasopharygeal Cancer
|ClinicalTrials.gov Identifier: NCT00095901|
Recruitment Status : Unknown
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : November 9, 2004
Last Update Posted : July 24, 2008
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|
- Determine the overall response rate (complete response and partial response) in patients with previously treated recurrent locoregional or metastatic carcinoma of the nasopharynx treated with capecitabine.
- Determine median progression-free survival of patients treated with this drug.
- Determine median overall survival of patients treated with this drug.
- Correlate tissue thymidine phosphorylase (TP) levels with response to this drug in these patients.
- Correlate the Epstein-Barr virus (EBV) status of these patients with response to this drug.
- Correlate survival with the EBV status of patients treated with this drug.
- Correlate TP levels with EBV status of patients treated with this drug.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|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|
- Response as assessed by RECIST criteria
- Stable disease, median duration of response, median duration of stable disease, and progression-free and overall survival curves as assessed by Kaplan-Meier
- Correlation of Epstein-Barr virus (EBV) with response as assessed by a two-sample t-test with arcsin approximation
- Safety as assessed by the CTC grading system once between days 1-14 and once after completion of study treatment
- Correlation of EBV status to thymidine phosphorylase expression as assessed by Fischer's exact test
- Correlation of response to thymidine phosphorylase expression as assessed by Fischer's exact test
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/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Lori J. Wirth, MD||Dana-Farber Cancer Institute|