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

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

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.

Study Overview

• Status: Completed
• Conditions: Nasopharyngeal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
  • Hong Kong, Hong Kong, 852
• Indonesia
  • Jogjakarta, Indonesia, 55284
• Malaysia
  • Kuala Lumpur, Malaysia, 50603
• Taiwan
  • Kueishan, Taiwan, 333
  • Taipei, Taiwan, 00112
  • Taipei, Taiwan, 106
• Thailand
  • Bangkok, Thailand, 10400
  • Bangkok, Thailand, 10330

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capecitabine + 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.	Drug: Capecitabine; 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).; Other Names: Xeloda; Drug: Cisplatin; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 18, 2015

Study Record Updates

• Last Update Posted (Estimate): March 2, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Cisplatin; Capecitabine
• Other Study ID Numbers: ML18123