A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer

Carcinoma, Hepatocellular Clinical Trial

Official title:

An Open-Label Phase II Study of Capecitabine in Combination With Pegylated Interferon Alfa-2a in Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576964
• Other study ID #: ML18269
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2015
• Last updated: November 1, 2016
• Start date: January 2005
• Est. completion date: November 2008

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Thai Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of capecitabine (Xeloda) in combination with peginterferon alfa-2a (Pegasys) in participants with advanced liver cancer who have had no prior treatment. The anticipated time on study treatment is until disease progression, and the target sample size is 43 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adults 18 to 75 years of age

• Locally advanced or metastatic liver cancer with measurable disease and not eligible for any standard therapy

Exclusion Criteria:

• Previous treatment for liver cancer

• Main portal vein involvement

• Bone, brain, or leptomeningeal metastasis

• Clinically significant cardiac disease

• Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract

• History of other cancer, except basal cell skin cancer or in situ cancer of the cervix

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

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Capecitabine
Participants will receive oral capecitabine, 1000 mg/m^2 twice daily on Days 1 to 14 of each 21-day cycle, for at least 6 cycles (18 weeks). Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal.
• Peginterferon alfa-2a
Participants will receive SC peginterferon alfa-2a, 180 mcg every week during each 21-day cycle, for at least 6 cycles (18 weeks). Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

China,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		up to post-chemotherapy follow-up ( approximately 46 months)	No
Secondary	Time to disease progression		Up to approximately 46 months	No
Secondary	Duration of response		Up to approximately 46 months	No
Secondary	Overall survival		Up to approximately 46 months	No
Secondary	Incidence of adverse events		Up to approximately 46 months	No