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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine; Interferon-alpha; Peginterferon alfa-2a

Criteria

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