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A Multi-center Phase II Trial of Capecitabine in Combination With Oxaliplatin (Xelox) as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma (NPC)

Phase 2
18 Years
75 Years
Open (Enrolling)
Nasopharyngeal Neoplasms

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Trial Information

A Multi-center Phase II Trial of Capecitabine in Combination With Oxaliplatin (Xelox) as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma (NPC)

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (based on RECIST criteria)

Outcome Time Frame:

From the beginning to the end of the study

Safety Issue:


Principal Investigator

Iris Chan

Investigator Role:

Study Director

Investigator Affiliation:



Hong Kong: Department of Health

Study ID:




Start Date:

July 2006

Completion Date:

Related Keywords:

  • Nasopharyngeal Neoplasms
  • Neoplasms
  • Carcinoma
  • Nasopharyngeal Neoplasms