Capecitabine in Treating Patients With Locally Recurrent or Metastatic Nasopharygeal Cancer
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|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
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/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Lori J. Wirth, MD||Dana-Farber Cancer Institute|