Trial Information

Summary: A Study of Avastin (Bevacizumab) and TACE Treatment in Patients With Liver Cancer.

Status: Recruiting

Protocol Number: ML21358

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: ?An open label study of the effect of Avastin pre- and post-transarterial chemoembolisation (TACE) treatment on progression-free survival in patients with localized unresectable hepatocellular carcinoma.

Brief Summary: This single arm, open label study will assess the efficacy and safety of Avastin treatment combined with transarterial chemoembolisation (TACE) in patients with localised unresectable liver cancer. Patients will be treated with TACE at 8 or 10 week intervals, and Avastin 5mg/kg iv will be administered 24-48 hours prior to first TACE and every 2 weeks thereafter. The anticipated time on study treatment is until disease progression or unmanageable toxicity, and the target sample size is <100 individuals. Target sample size is 40.

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: bevacizumab [Avastin]

Primary Outcome: 1. Progression-free survival Time frame: Event driven

Key Secondary Outcomes: 1. Overall response rate, time to progression, disease control rate, overall survival, tumor necrosis rate. Time frame: Event driven 2. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • liver cancer, not suitable for resection;
  • at least one measurable lesion, and overall tumor lesions occupying <50% of liver volume;
  • ECOG performance status 0-2.

Exclusion Criteria:

  • patients receiving concurrent radiotherapy or immunotherapy;
  • patients who have received previous chemotherapy, biological agents or radiotherapy;
  • prior TACE or TAE;
  • prior liver transplantation or liver resection;
  • current or recent (within 10 days of study start) use of full-dose anticoagulants for therapeutic purposes;
  • patients with high risk esophageal/gastric varices.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: February, 2008

Trial Registration Date: 12/17/2007

Date Last Updated: 10/16/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Hong Kong, China, 852
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: November 17, 2008 at 2:49:57 PM


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