Trial Information

Summary: A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer

Status: No longer recruiting

Protocol Number: ML18469

Sponsor: Roche Products Ltd.

Company Division: Pharmaceutical

Official Scientific Title: A single-arm, open-label study of Avastin plus Xeloda on objective treatment response in patients with advanced or metastatic liver cancer who have had no previous cytotoxic chemotherapy

Brief Summary: This study will evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months, 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:

Condition: Liver Cancer

Intervention Type: Drug

Intervention Name: bevacizumab[Avastin]

Primary Outcome: 1. Objective response rate through tumor measurement and assessment

Key Secondary Outcomes: 1. Disease control rate (complete response plus partial response plus stable disease), time to disease progression, and overall survival . Safety profile

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2005

Trial Registration Date: 08/29/2005

Date Last Updated: 05/16/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:29:41 PM