Clincosm LogoSign in Get a demo

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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02576964
Collaborator
(none)
16
Enrollment
8
Locations
1
Arm
46
Duration (Months)
2
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Phase II Study of Capecitabine in Combination With Pegylated Interferon Alfa-2a in Patients With Advanced Hepatocellular Carcinoma
Study Start Date :
Jan 1, 2005
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Capecitabine + Peginterferon alfa-2a

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
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.
Other Names:
  • Xeloda

    • Drug: 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.
    Other Names:
  • Pegasys

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate [up to post-chemotherapy follow-up ( approximately 46 months)]

    Secondary Outcome Measures

    1. Time to disease progression [Up to approximately 46 months]

    2. Duration of response [Up to approximately 46 months]

    3. Overall survival [Up to approximately 46 months]

    4. Incidence of adverse events [Up to approximately 46 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing China 100050
    2 Guangzhou China 510060
    3 Kueishan Taiwan 333
    4 Tainan Taiwan 704
    5 Bangkok Thailand 10400
    6 Bangkok Thailand 10700
    7 Chiang Mai Thailand 50202
    8 Songkhla Thailand 90112

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Chair: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02576964
    Other Study ID Numbers:
    • ML18269
    First Posted:
    Oct 15, 2015
    Last Update Posted:
    Nov 2, 2016
    Last Verified:
    Nov 1, 2016
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Peginterferon alfa-2a
    Capecitabine

    Study Results

    No Results Posted as of Nov 2, 2016