Combination of Capecitabine and Oxaliplatin in Metastatic Nasopharyngeal Carcinoma

Inclusion Criteria:

* Histologically confirmed poorly differentiated or undifferentiated nasopharyngeal carcinoma (WHO type II and III) with distant metastasis (ie. other than loco-regional disease). Patients with stage IVc disease, ie. distant metastases on presentation are also eligible.
* Have at least one measurable lesion according to RECIST which has not been irradiated.
* WBC count ≥ 3 x 10\^9 /L with neutrophils ≥ 1.5 x 10\^9 /L, platelet count ≥ 100 x 10\^9 /L and Hb ≥ 9g/dL.
* Serum creatinine ≤ 1.25 ULN
* Be ambulatory and have a Karnofsky Performance Status of ≥ 70% at study entry.
* Recover from prior radiotherapy prior to study entry
* Effective contraception for both male and female if the risk of conception exists.
* Able to swallow and retain oral medication.

Exclusion Criteria:

* Previous cytotoxic chemotherapy for recurrent or metastatic NPC.
* Previous exposure to oxaliplatin and/or capecitabine.
* Pregnant or lactating women. Women of childbearing potential with either positive or no pregnancy test at baseline. Women 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)
* Sexually active males unwilling to practice contraception during the study.
* Clinically significant cardiac disease (eg. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
* Patients with a history of central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
* Abnormal blood counts, AST, ALT, bilirubin and/or serum creatinine beyond the limits specified in the inclusion criteria.
* Radiotherapy within 4 weeks of treatment start or prior radiotherapy to the indicator lesion(s) being measured in the study (newly arising marker lesions in previously irradiated areas are acceptable).
* Major surgery within 4 weeks of the start of study treatment, without complete recovery.
* Participation in any investigational drug study within 4 weeks preceding the start of treatment.
* Symptomatic peripheral neuropathy NCI-CTCAE grade ≥ 2.
* Known allergic/hypersensitivity reaction to any of the components of study treatments.
* Serious uncontrolled intercurrent infections.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.