Transarterial Chemoembolisation Plus Bevacizumab for Treatment of Hepatocellular Carcinoma

NCT00280007 | Terminated Phase 2

• 1 other identifier: MPR-2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with liver cirrhosis and hepatocellular carcinoma will undergo transarterial chemoembolisation (TACE) as clinically indicated and will be randomized to receive bevacizumab or placebo every 2 weeks up to 1 year. Tumor response will be assessed using MR of the liver and PET-scanning. It will be tested whether the addition of bevacizumab as angiogenic inhibitor will slow down tumor progression, reduce the need for re-embolisation and will improve patient survival.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; TACE; transarterial chemoembolisation; portal hypertension; angiogenesis; VEGF; bevacizumab

Outcome Measures

Primary Outcomes (2)

• to assess the effectiveness of bevacizumab in combination with TACE as measured by patients without tumor progression after a maximum of one year treatment with bevacizumab

  12 months

• to assess collateral tumor vessel growth on MRT / CT after 3, 6, and 12 months

  12 months

Secondary Outcomes (9)

• overall survival

  12 months

• time to progression

  12 months

• safety

  12 months

• total number of TACE-cycles applied

  12 months

• metabolically active tumor size on PET-scan

  12 months

Study Arms (2)

1

EXPERIMENTAL

bevacizumab infusion evey 2 weeks

Drug: bevacizumab

2

PLACEBO COMPARATOR

placebo infusion

Drug: bevacizumab

Interventions

bevacizumab DRUG

bevacizumab 5 mg/kg i.v. every 14 days for 52 weeks

Also known as: -avastin

1; 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed HCC not suitable for OLT or resection (\>3 nodules, \>5 cm diameter, vascular invasion, clinically significant portal hypertension, other contraindications against OLT) or patients awaiting OLT with an expected waiting time \>12 months
• Child-Pugh Stage A and B
• Liver disease of any etiology
• Written informed consent (approved by the Institutional Review Board \[IRB\]/Independent Ethics Committee \[IEC\]) obtained prior to any study specific screening procedures
• Patient must be able to comply with the protocol
• Age ≥18 years
• Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. Fertile women and men of childbearing potential (\<2 years after last menstruation in women) must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
• Proteinuria at baseline:
• Urine dipstick of proteinuria \<2+. Patients discovered to have \>2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate less \<= 1 g of protein/24 hr.
• Haematology:
• Absolute neutrophil count (ANC) \> 1 x 109/L
• Platelet count \> 40 x 109/L
• Haemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level)
• Prothrombin time \>= 40%
• Biochemistry:

You may not qualify if:

• extra hepatic tumor spread
• complete portal vein thrombosis (common trunk)
• Child-Pugh-Stage C
• Prior TACE or TAE
• Other experimental therapies for HCC
• Acute variceal bleeding within the last 2 weeks
• Large oesophageal varices (\>5 mm diameter) without prophylactic band ligation
• Past or current history (within the last 2 years prior to randomisation) of malignancies except for the indication under this study and curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
• History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy or history of stroke within \< 6 months), excluding hepatic encephalopathy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study
• Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants for therapeutic purposes
• Chronic, daily treatment with aspirin (\>325mg/day)
• Pregnancy (positive serum pregnancy test) or lactation
• Uncontrolled hypertension
• Serious, non-healing wound, ulcer, or bone fracture

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medizinische Universität Wien

Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hypertension, Portal

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; 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

Study Officials

• Markus Peck-Radosavljevic, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 19, 2006
• First Posted: January 20, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: April 22, 2010

Record last verified: 2009-09

Locations

AU (1)