A Multi-center Phase II Trial of Capecitabine in Combination With Oxaliplatin (Xelox) as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma (NPC)
- 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
- Have at least one measurable lesion according to RECIST which has not been
- 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.
- 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
- Participation in any investigational drug study within 4 weeks preceding the start of
- Symptomatic peripheral neuropathy NCI-CTCAE grade ≥ 2.
- Known allergic/hypersensitivity reaction to any of the components of study
- 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.