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
1 other identifier
interventional
25
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2007
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2007
CompletedFirst Posted
Study publicly available on registry
February 23, 2007
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedNovember 2, 2016
November 1, 2016
2.4 years
February 22, 2007
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate
Event driven
Secondary Outcomes (2)
Time to disease progression or death, survival time, duration of response, complete response rate.
Event driven
AEs, laboratory parameters.
Throughout study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- previous cytotoxic chemotherapy;
- radiotherapy within 4 weeks of treatment start;
- history of another malignancy within the last 5 years;
- clinically significant cardiac disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Agadir, 80000, Morocco
Unknown Facility
Casablanca, 20502, Morocco
Unknown Facility
Marrakesh, 40000, Morocco
Unknown Facility
Rabat, 10000, Morocco
Unknown Facility
Rabat, 6213, Morocco
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2007
First Posted
February 23, 2007
Study Start
April 1, 2007
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
November 2, 2016
Record last verified: 2016-11