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

Nasopharyngeal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608073
• Other study ID #: ML18123
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2015
• Last updated: March 1, 2016
• Start date: November 2004
• Est. completion date: November 2009

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of HealthTaiwan: Department of HealthMalaysia: Ministry of HealthThailand: Ministry of Public HealthIndonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasopharyngeal Cancer
• Nasopharyngeal Neoplasms

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Hong Kong,  Indonesia,  Malaysia,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		up to 28 days after the last intake of study treatment (up to approximately 5 years)	No
Secondary	Overall survival		Up to approximately 18 months	No
Secondary	Time to disease progression		Up to approximately 18 months	No
Secondary	Duration of response		Up to approximately 18 months	No
Secondary	Complete response rate		Up to approximately 18 months	No
Secondary	Incidence of adverse events		Up to approximately 7 months	No
Secondary	Quality of life according to Visual Analog Scale (VAS) score		Up to approximately 6 months	No
Secondary	Treatment convenience/satisfaction according to VAS score		Up to approximately 6 months	No