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

Phase 2

Completed

• Conditions: Nasopharyngeal Cancer
• Interventions: Drug: Capecitabine; Drug: Cisplatin

• Registration Number: NCT02608073
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capecitabine + Cisplatin	Cisplatin	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.
Capecitabine + Cisplatin	Capecitabine	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.

Primary Outcome Measures

Name	Time	Method
Overall response rate	up to 28 days after the last intake of study treatment (up to approximately 5 years)

Secondary Outcome Measures

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