Back to resultsA Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer
Primary Purpose
Nasopharyngeal Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Capecitabine
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Cancer
Eligibility Criteria
Inclusion Criteria:
- Adults 18 to 75 years of age
- Histologically confirmed, poorly differentiated or undifferentiated metastatic nasopharyngeal cancer with at least 1 measurable lesion which has not been irradiated
- Ability to swallow and retain oral medication
Exclusion Criteria:
- Previous cytotoxic chemotherapy except adjuvant, concurrent, or neoadjuvant treatment completed at least 6 months before enrollment
- Clinically significant cardiac disease
- History of other malignancy within the last 5 years except cured basal cell cancer of the skin or cured cancer in situ of the cervix
- Radiotherapy within 4 weeks of treatment start or any prior radiotherapy performed to the indicator lesion(s) being measured in the study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Capecitabine + Cisplatin
Arm Description
Participants with metastatic nasopharyngeal cancer will receive combination treatment with capecitabine (1000 milligrams per meter square [mg/m^2] tablets twice daily [BID] orally) and cisplatin (100 mg/m^2/day intravenous [IV] infusion) for up to 8 cycles.
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
Overall survival
Time to disease progression
Duration of response
Complete response rate
Incidence of adverse events
Quality of life according to Visual Analog Scale (VAS) score
Treatment convenience/satisfaction according to VAS score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02608073
Brief Title
A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer
Official Title
A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 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 study will evaluate the efficacy, safety, tolerability, and effect on quality of life of oral capecitabine in combination with intravenous (IV) cisplatin in participants with metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine treatment, and cisplatin will be administered on the first day of each cycle. The anticipated time on study treatment is up to 24 weeks, and the target sample size is 44 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
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine + Cisplatin
Arm Type
Experimental
Arm Description
Participants with metastatic nasopharyngeal cancer will receive combination treatment with capecitabine (1000 milligrams per meter square [mg/m^2] tablets twice daily [BID] orally) and cisplatin (100 mg/m^2/day intravenous [IV] infusion) for up to 8 cycles.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Participants will receive oral capecitabine, 1000 mg/m^2 BID on Days 1 to 14 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Participants will receive cisplatin, 100 mg/m^2 via IV infusion on Day 1 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
up to 28 days after the last intake of study treatment (up to approximately 5 years)
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Up to approximately 18 months
Title
Time to disease progression
Time Frame
Up to approximately 18 months
Title
Duration of response
Time Frame
Up to approximately 18 months
Title
Complete response rate
Time Frame
Up to approximately 18 months
Title
Incidence of adverse events
Time Frame
Up to approximately 7 months
Title
Quality of life according to Visual Analog Scale (VAS) score
Time Frame
Up to approximately 6 months
Title
Treatment convenience/satisfaction according to VAS score
Time Frame
Up to approximately 6 months
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:
Adults 18 to 75 years of age
Histologically confirmed, poorly differentiated or undifferentiated metastatic nasopharyngeal cancer with at least 1 measurable lesion which has not been irradiated
Ability to swallow and retain oral medication
Exclusion Criteria:
Previous cytotoxic chemotherapy except adjuvant, concurrent, or neoadjuvant treatment completed at least 6 months before enrollment
Clinically significant cardiac disease
History of other malignancy within the last 5 years except cured basal cell cancer of the skin or cured cancer in situ of the cervix
Radiotherapy within 4 weeks of treatment start or any prior radiotherapy performed to the indicator lesion(s) being measured in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
City
Hong Kong
Country
Hong Kong
City
Jogjakarta
ZIP/Postal Code
55284
Country
Indonesia
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
City
Kueishan
ZIP/Postal Code
333
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer
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