A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Cancer

Intervention / Treatment
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* Drug: Capecitabine
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine + Cisplatin<br>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. | Drug: Capecitabine<br>* 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).<br>* Other names: Xeloda;Drug: Cisplatin<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | up to 28 days after the last intake of study treatment (up to approximately 5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Up to approximately 18 months | 
| Time to disease progression |  | Up to approximately 18 months | 
| Duration of response |  | Up to approximately 18 months | 
| Complete response rate |  | Up to approximately 18 months | 
| Incidence of adverse events |  | Up to approximately 7 months | 
| Quality of life according to Visual Analog Scale (VAS) score |  | Up to approximately 6 months | 
| Treatment convenience/satisfaction according to VAS score |  | Up to approximately 6 months |