This trial is active, not recruiting.

Condition head and neck cancer
Treatment capecitabine
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date June 2004
Trial identifier NCT00095901, CDR0000393550, DFCI-03384


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Response as assessed by RECIST criteria
time frame:
Stable disease, median duration of response, median duration of stable disease, and progression-free and overall survival curves as assessed by Kaplan-Meier
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Study Of Capecitabine In Previously Treated, Recurrent And/Or Metastatic Nasopharyngeal Carcinoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).