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	Treatment or Intervention	Phase
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	Drug: capecitabine  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 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

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202,  United States; Recruiting
Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States; Recruiting
Missouri
      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting

Study chairs or principal investigators

Lori J. Wirth, MD,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000393550; DFCI-03384; NCT00095901
Record last reviewed:  October 2004
Last Updated:  April 4, 2005
Record first received:  November 9, 2004
ClinicalTrials.gov Identifier:  NCT00095901
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08