Trial Information

Summary: A Study of Xeloda (Capecitabine) and PEGASYS in Treatment-Naive Patients With Advanced Liver Cancer

Status: No longer recruiting

Protocol Number: ML18269

Sponsor: Roche Thailand Ltd

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of Xeloda in combination with Pegasys on overall treatment response in treatment-naïve patients with advanced liver cancer

Brief Summary: This study will evaluate the efficacy and safety of Xeloda in combination with Pegasys in patients with advanced liver cancer who have had no prior treatment. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals. Target sample size is 43.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Liver Cancer

Intervention Type: Drug

Intervention Name: capecitabine[Xeloda]

Primary Outcome: 1. Objective response rate

Key Secondary Outcomes: 1. Efficacy: Time to disease progression, duration of response, and overall survival. Safety: Adverse events and laboratory tests

Inclusion Criteria:

  • adults patients 18-75 years of age;
  • locally advanced or metastatic liver cancer;
  • measurable disease;
  • not eligible for any standard therapy.

Exclusion Criteria:

  • previous treatment for liver cancer;
  • main portal vein involvement;
  • bone, brain, or leptomeningeal metastasis;
  • history of clinically significant cardiac disease;
  • lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome;
  • history of cancer, except basal cell skin cancer or in situ cancer of the cervix.

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: January, 2005

Trial Registration Date: 09/26/2005

Date Last Updated: 07/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Guangzhou, China, 510630
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: July 21, 2008 at 2:17:28 PM


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