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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: February 22, 2007
Last updated: March 9, 2015
Last verified: March 2015

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.

Condition Intervention Phase
Nasopharyngeal Cancer
Drug: capecitabine [Xeloda]
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study of First Line Chemotherapy With Xeloda in Combination With Cisplatin on Treatment Response in Patients With Metastatic Nasopharyngeal Cancer

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression or death, survival time, duration of response, complete response rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: April 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle
Drug: Oxaliplatin
130mg/m2 iv on day 1 of each 3 week cycle


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00439426

Agadir, Morocco, 80000
Casablanca, Morocco, 20502
Marrakech, Morocco, 40000
Rabat, Morocco, 10000
Rabat, Morocco, 6213
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00439426     History of Changes
Other Study ID Numbers: ML20508
Study First Received: February 22, 2007
Last Updated: March 9, 2015
Health Authority: Morocco: Ministry of Health

ClinicalTrials.gov processed this record on March 26, 2015