Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma

April 2, 2008 updated by: Pfizer

A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable Hepatocellular Carcinoma

To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Pfizer Investigational Site
  • Hong Kong
      • Hong Kong SAR, Hong Kong
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 152-703
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 136-705
        • Pfizer Investigational Site
  • Taiwan
      • Keelung, Taiwan, 204
        • Pfizer Investigational Site
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
      • Taipei, Taiwan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma
  • Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement)
  • Eastern Cooperative Oncology Group performance status of ?2

Exclusion Criteria:

  • Decompensated cirrhosis or stage C (Index>10) according to the Child-Pugh Classification
  • Current history of chronic diarrhoea
  • Reproductive potential not using adequate contraceptive measures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Irinotecan plus capecitabine
Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: Week 6
Week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year
Weeks 6, 12, 18, 24, 36, and 1 year
Duration of overall response
Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year
Weeks 6, 12, 18, 24, 36, and 1 year
Overall tumour growth control rate
Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year
Weeks 6, 12, 18, 24, 36, and 1 year
Overall survival
Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year
Weeks 6, 12, 18, 24, 36, and 1 year
Adverse events
Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year
Weeks 6, 12, 18, 24, 36, and 1 year
Physical exam
Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year
Weeks 6, 12, 18, 24, 36, and 1 year
Laboratory tests
Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year
Weeks 6, 12, 18, 24, 36, and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

April 7, 2008

Last Update Submitted That Met QC Criteria

April 2, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XRP4174/2501
  • A5961080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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