An Open Label Study of First Line Chemotherapy With Xeloda in Combination With Cisplatin on Treatment Response in Patients With Metastatic Nasopharyngeal Cancer
Phase 2
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Nasopharyngeal Cancer
Both
Nasopharyngeal Cancer
Trial Information
An Open Label Study of First Line Chemotherapy With Xeloda in Combination With Cisplatin on Treatment Response in Patients With Metastatic Nasopharyngeal Cancer
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.
Type of Study:
Interventional
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
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Morocco: Ministry of Health
Study ID:
ML20508
NCT ID:
NCT00439426
Start Date:
April 2007
Completion Date:
September 2009
Related Keywords:
- Nasopharyngeal Cancer
- Nasopharyngeal Neoplasms
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