A Study of Avastin (Bevacizumab) and Transarterial Chemoembolisation (TACE) Treatment in Patients With Liver Cancer

NCT00576199 | Completed Phase 2 Results

• 1 other identifier: ML21358
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This single-arm, open-label study assessed the efficacy and safety of Avastin (bevacizumab) treatment combined with transarterial chemoembolisation (TACE) in patients with localized unresectable liver cancer. Patients were treated with TACE at 8 or 10 week intervals for 4 sessions (continuation depended on investigator's discretion). Avastin 5 mg/kg intravenously was administered 24-48 hours prior to each TACE session and every 2 weeks between the TACE sessions until disease progression.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.

  Baseline to the end of the study (up to 3 years, 3 months)

Secondary Outcomes (5)

• Percentage of Participants With an Objective Response

  Baseline to the end of the study (up to 3 years, 3 months)

• Time to Progression

  Baseline to the end of the study (up to 3 years, 3 months)

• Overall Survival

  Baseline to the end of the study (up to 3 years, 3 months)

• Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, or Stable Disease

  Baseline to the end of the study (up to 3 years, 3 months)

• Tumor Necrosis

  Baseline to the end of the study (up to 3 years, 3 months)

Study Arms (1)

Bevacizumab 5 mg/kg

EXPERIMENTAL

Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.

Drug: Bevacizumab; Procedure: Transarterial chemoembolisation (TACE)

Interventions

Bevacizumab DRUG

Bevacizumab was supplied as a sterile liquid in single-use vials.

Also known as: Avastin

Bevacizumab 5 mg/kg

Transarterial chemoembolisation (TACE) PROCEDURE

TACE was conducted by the transfemoral artery approach with selective cannulation of the artery supplying the tumor. Cisplatin mixed with Lipiodol in a 1 mg:1 mL ratio was infused intra-arterially up to a maximum dose of 30 mg, depending on tumor size, followed by embolization of the artery using Gelfoam particle until the blood flow slowed. Bilobar lesions were treated by separate catheterization of right and left hepatic arteries followed by injection of the cisplatin-Lipiodol mixture and embolization. Patients with stable disease or a partial response after 4 TACE sessions could be given further TACEs upon the investigator's discretion until there was evidence of progressive disease or contraindication due to severe complication or technical failure to perform the TACE.

Bevacizumab 5 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, ≥ 18 years of age.
• Liver cancer, not suitable for resection.
• At least 1 measurable lesion, and overall tumor lesions occupying \< 50% of liver volume
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

You may not qualify if:

• Patients receiving concurrent radiotherapy or immunotherapy.
• Patients who have received previous chemotherapy, biological agents, or radiotherapy.
• Prior transarterial chemoembolisation (TACE) or transarterial embolisation (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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Hong Kong, 0, Hong Kong

Location

Unknown Facility

Hong Kong, 852, Hong Kong

Location

Unknown Facility

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 19, 2007
• Study Start: February 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 29, 2014
• Results First Posted: August 29, 2014

Record last verified: 2014-08

Locations

HK (3)