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

Study Overview
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Brief Summary
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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.

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

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Drug: Capecitabine
* Drug: Peginterferon alfa-2a


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine + Peginterferon alfa-2a<br>Treatment-naive participants with advanced liver cancer will receive combination treatment with capecitabine (1000 milligrams per meter-squared [mg/m^2] twice daily orally on Days 1 to 14 of each 21-day cycle) and peginterferon alfa-2a (180 micrograms (mcg) subcutaneous [SC] every week during each 21-day cycle) until at least 6 cycles (18 weeks) or disease progression, intolerable toxicity, or consent withdrawal. | Drug: Capecitabine<br>* 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.<br>* Other names: Xeloda;Drug: Peginterferon alfa-2a<br>* 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.<br>* Other names: Pegasys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | up to post-chemotherapy follow-up ( approximately 46 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression |  | Up to approximately 46 months | 
| Duration of response |  | Up to approximately 46 months | 
| Overall survival |  | Up to approximately 46 months | 
| Incidence of adverse events |  | Up to approximately 46 months |