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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02608073
• Date of registration: 16/11/2015
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer
• Scientific title: A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma
• Date of first enrolment: November 2004
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02608073
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Hong Kong, Indonesia, Malaysia, Taiwan, Thailand

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Nasopharyngeal Cancer

Intervention(s)

Drug: Capecitabine

Drug: Cisplatin

Primary Outcome(s)

Overall response rate [Time Frame: up to 28 days after the last intake of study treatment (up to approximately 5 years)]

Secondary Outcome(s)

Duration of response [Time Frame: Up to approximately 18 months]

Incidence of adverse events [Time Frame: Up to approximately 7 months]

Quality of life according to Visual Analog Scale (VAS) score [Time Frame: Up to approximately 6 months]

Overall survival [Time Frame: Up to approximately 18 months]

Time to disease progression [Time Frame: Up to approximately 18 months]

Complete response rate [Time Frame: Up to approximately 18 months]

Treatment convenience/satisfaction according to VAS score [Time Frame: Up to approximately 6 months]

Secondary ID(s)

ML18123

Source(s) of Monetary Support

Please refer to primary and secondary sponsors