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Capecitabine in Treating Patients With Locally Recurrent or Metastatic Nasopharygeal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

Detailed Description:



  • 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)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Capecitabine In Previously Treated, Recurrent And/Or Metastatic Nasopharyngeal Carcinoma
Study Start Date : June 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Response as assessed by RECIST criteria
  2. Stable disease, median duration of response, median duration of stable disease, and progression-free and overall survival curves as assessed by Kaplan-Meier

Secondary Outcome Measures :
  1. Correlation of Epstein-Barr virus (EBV) with response as assessed by a two-sample t-test with arcsin approximation
  2. Safety as assessed by the CTC grading system once between days 1-14 and once after completion of study treatment
  3. Correlation of EBV status to thymidine phosphorylase expression as assessed by Fischer's exact test
  4. Correlation of response to thymidine phosphorylase expression as assessed by Fischer's exact test

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed carcinoma of the nasopharynx

    • WHO type I, II, or III
    • Recurrent locoregional or metastatic disease
    • The following primary tumor sites or types are excluded:

      • Nasal cavity
      • Paranasal sinus
      • Sinonasal neuroendocrine carcinoma
      • Primary malignancy of the salivary gland
  • Received at least 1, but no more than 2, prior chemotherapy regimens for recurrent locoregional or metastatic disease

    • Patients who are intolerant of OR have a condition that precludes platinum-based chemotherapy are eligible
  • Available tumor tissue
  • Measurable disease

    • At least 1 lesion that has not been irradiated within the past 6 months
    • More than 10 mm by spiral CT scan (20 mm by conventional techniques)
    • Pleural effusion or bone metastases are not considered measurable disease
  • No CNS metastases unless stable for > 3 months



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months


  • Neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (5 times ULN if due to liver metastases)
  • Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if due to liver metastases; 10 times ULN if due to bone metastases)


  • Creatinine clearance ≥ 30 mL/min OR
  • Creatinine ≤ 1.5 times ULN


  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No cardiac arrhythmias not well controlled by medication
  • No myocardial infarction within the past year
  • No other clinically significant cardiac disease


  • No history of uncontrolled seizures
  • No clinically significant CNS disorder or psychiatric disability that would preclude giving informed consent or complying with study treatment


  • No prior unanticipated severe reaction to fluoropyrimidines
  • No extreme sensitivity to fluorouracil
  • No serious, uncontrolled infection


  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No malabsorption syndrome of the upper gastrointestinal tract
  • No other serious uncontrolled medical condition that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • More than 6 months since prior fluoropyrimidines, including fluorouracil
  • More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy


  • More than 4 weeks since prior major surgery and recovered


  • More than 4 weeks since prior investigational drugs

Information from the National Library of Medicine

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
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Lori J. Wirth, MD Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier: NCT00095901     History of Changes
Other Study ID Numbers: CDR0000393550
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: December 2005

Keywords provided by National Cancer Institute (NCI):
recurrent squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents