Back to resultsA Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer
Primary Purpose
Carcinoma, Hepatocellular
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Capecitabine
Peginterferon alfa-2a
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Capecitabine + Peginterferon alfa-2a
Arm Description
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.
Outcomes
Primary Outcome Measures
Objective response rate
Secondary Outcome Measures
Time to disease progression
Duration of response
Overall survival
Incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02576964
Brief Title
A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer
Official Title
An Open-Label Phase II Study of Capecitabine in Combination With Pegylated Interferon Alfa-2a in Patients With Advanced Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capecitabine + Peginterferon alfa-2a
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
up to post-chemotherapy follow-up ( approximately 46 months)
Secondary Outcome Measure Information:
Title
Time to disease progression
Time Frame
Up to approximately 46 months
Title
Duration of response
Time Frame
Up to approximately 46 months
Title
Overall survival
Time Frame
Up to approximately 46 months
Title
Incidence of adverse events
Time Frame
Up to approximately 46 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Beijing
ZIP/Postal Code
100050
Country
China
City
Guangzhou
ZIP/Postal Code
510060
Country
China
City
Kueishan
ZIP/Postal Code
333
Country
Taiwan
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50202
Country
Thailand
City
Songkhla
ZIP/Postal Code
90112
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer
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