Capecitabine For Nasopharyngeal Cancer

This is a nonrandomized, multicenter study.

- Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21
days.

- Inclusion Criteria

- To be eligible for inclusion, each patient must fulfill each of the following
criteria:

- Provide written informed consent prior to study-specific screening procedures,
with the understanding that the patient has the right to withdraw from the study
at any time, without prejudice.

- At least 18 years of age.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (see Appendix
C).

- Histologically confirmed nasopharyngeal carcinoma, WHO types I, II or III, with
recurrent locoregional and/or metastatic disease. Primary cancers of the nasal
cavity or paranasal sinuses, sinonasal neuroendocrine carcinomas or primary
malignancies of the salivary gland will NOT be eligible.

- Have received at least one, but no more than 2, prior chemotherapy regimens for
recurrent and/or metastatic disease. Patients with recurrent locoregional and/or
metastatic NPC who are unable to tolerate a platinum-based chemotherapy due to
previous treatment with a platinum or a condition that precludes their use will
also be eligible.

- Have tumor tissue available for EBER analysis, if not already done.

- Have at least one measurable lesion according to the RECIST criteria (see
Appendix B) which has not been irradiated within 6 months of enrollment. Pleural
effusion and bone metastases are not considered measurable. Minimum indicator
lesion size: ≥ 10 mm measured by spiral CT or ≥ 20 mm measured by conventional
techniques.

- Have a negative serum or urine pregnancy test within 7 days prior to registration
in female patients of childbearing potential.

- Exclusion Criteria

- Patients who fulfill any of the following criteria will be excluded:

- Pregnant or lactating women. Women of childbearing potential with either a
positive or no pregnancy test at baseline. Women or men of childbearing potential
not using a reliable and appropriate contraceptive method. (Postmenopausal women
must have been amenorrheic for at least 12 months to be considered of
non-childbearing potential).

- Life expectancy <3 months.

- Serious, uncontrolled, concurrent infection(s).

- Prior fluoropyrimidine therapy within 6 months of enrollment. Subjects with
previous 5-FU or other fluoropyrimidine treatment are eligible, if ≥ 6 months has
elapsed since this previous therapy.

- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known extreme
sensitivity to 5-FU.

- Completion of previous chemotherapy regimen < 4 weeks prior to the start of study
treatment, or with related toxicities unresolved prior to the start of study
treatment.

- Previous radiotherapy < 4 weeks prior to the start of study treatment.

- Other malignancy within the last five years, except non-melanoma skin and in-situ
cervical cancer.

- Participation in any investigational drug study within 4 weeks preceding the
start of study treatment.

- Clinically significant cardiac disease (e.g. congestive heart failure,
symptomatic coronary artery disease and cardiac arrhythmias not well controlled
with medication) or myocardial infarction within the last 12 months.

- Evidence of central nervous system (CNS) metastases (unless CNS metastases have
been stable for > 3 months) or history of uncontrolled seizures, central nervous
system disorders or psychiatric disability judged by the investigator to be
clinically significant, precluding informed consent, or interfering with
compliance of oral drug intake. Other serious uncontrolled medical conditions
that the investigator feels might compromise study participation.

- Major surgery within 4 weeks of the start of study treatment, without complete
recovery.

- Malabsorption syndrome of the upper gastrointestinal tract.

- Any of the following laboratory values:

- Abnormal hematologic values (neutrophils < 1.5 x 10 9/L, platelet count <
100 x 10 9/L)

- Impaired renal function (estimated creatinine clearance <30 ml/min as
calculated with Cockroft-Gault equation or serum creatinine > 1.5 x upper
normal limit).

- Note: In patients with moderate renal impairment (estimated creatinine
clearance 30-50 mL/min) at baseline, a dose reduction to 75% of the
capecitabine starting dose is recommended.

- Serum bilirubin > 1.5 x upper normal limit.

- ALT, AST > 2.5 x upper normal limit (or > 5 x upper normal limit in the case
of liver metastases).

- Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit
in the case of liver metastases or > 10 x upper normal limit in the case of
bone disease).

- Unwillingness to give written informed consent.

- Unwillingness to participate or inability to comply with the protocol for the
duration of the study.

- Other serious uncontrolled medical conditions that the investigator feels might
compromise study participation