Back to resultsA Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.
Primary Purpose
Nasopharyngeal Cancer
Status
Completed
Phase
Phase 2
Locations
Morocco
Study Type
Interventional
Intervention
Oxaliplatin
capecitabine [Xeloda]
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
Time to disease progression or death, survival time, duration of response, complete response rate.
AEs, laboratory parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00439426
Brief Title
A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130mg/m2 iv on day 1 of each 3 week cycle
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
1000mg/m2 po bid on days 1-14 of each 3 week cycle
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
Event driven
Secondary Outcome Measure Information:
Title
Time to disease progression or death, survival time, duration of response, complete response rate.
Time Frame
Event driven
Title
AEs, laboratory parameters.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Agadir
ZIP/Postal Code
80000
Country
Morocco
City
Casablanca
ZIP/Postal Code
20502
Country
Morocco
City
Marrakech
ZIP/Postal Code
40000
Country
Morocco
City
Rabat
ZIP/Postal Code
10000
Country
Morocco
City
Rabat
ZIP/Postal Code
6213
Country
Morocco
12. IPD Sharing Statement
Learn more about this trial
A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.
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