Capecitabine in Treating Patients With Locally Recurrent or Metastatic Nasopharygeal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00095901
First received: November 9, 2004
Last updated: July 23, 2008
Last verified: December 2005
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: capecitabine
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Capecitabine In Previously Treated, Recurrent And/Or Metastatic Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Stable disease, median duration of response, median duration of stable disease, and progression-free and overall survival curves as assessed by Kaplan-Meier [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of Epstein-Barr virus (EBV) with response as assessed by a two-sample t-test with arcsin approximation [ Designated as safety issue: No ]
  • Safety as assessed by the CTC grading system once between days 1-14 and once after completion of study treatment [ Designated as safety issue: Yes ]
  • Correlation of EBV status to thymidine phosphorylase expression as assessed by Fischer's exact test [ Designated as safety issue: No ]
  • Correlation of response to thymidine phosphorylase expression as assessed by Fischer's exact test [ Designated as safety issue: No ]

Study Start Date: June 2004
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months

Hematopoietic

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

Hepatic

  • 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)

Renal

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

Cardiovascular

  • 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

Neurologic

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

Immunologic

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • More than 4 weeks since prior major surgery and recovered

Other

  • More than 4 weeks since prior investigational drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095901

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Lori J. Wirth, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00095901     History of Changes
Other Study ID Numbers: CDR0000393550, DFCI-03384
Study First Received: November 9, 2004
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

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
Neoplasms
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014