A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.

An Open Label Study of First Line Chemotherapy With Xeloda in Combination With Cisplatin on Treatment Response in Patients With Metastatic Nasopharyngeal Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00439426

Enrollment

Registered

2007-02-23

Start date

2007-04-30

Completion date

2009-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Cancer

Brief summary

This single arm study will assess the efficacy and safety of Xeloda + oxaliplatin when given as first line treatment for patients with metastatic nasopharyngeal cancer. Patients will receive Xeloda (1000mg/m2 bid orally from day 1 to day 14, followed by a rest period of 7 days) plus oxaliplatin (130mg/m2 iv infusion on day 1 of each 21 day cycle) for 6-8 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Interventions

DRUGOxaliplatin

130mg/m2 iv on day 1 of each 3 week cycle

DRUGcapecitabine [Xeloda]

1000mg/m2 po bid on days 1-14 of each 3 week cycle

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-75 years of age; * history of nasopharyngeal cancer and distant metastases; * no previous chemotherapy in past 6 months; * recovery from previous radiotherapy; * ability to swallow and retain oral medication.

Exclusion criteria

* previous cytotoxic chemotherapy; * radiotherapy within 4 weeks of treatment start; * history of another malignancy within the last 5 years; * clinically significant cardiac disease.

Design outcomes

Primary

Measure	Time frame
Overall response rate	Event driven

Secondary

Measure	Time frame
Time to disease progression or death, survival time, duration of response, complete response rate.	Event driven
AEs, laboratory parameters.	Throughout study

Countries

Morocco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026