A Study of Avastin (Bevacizumab) and TACE Treatment in Patients With Liver Cancer.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576199
First received: December 18, 2007
Last updated: August 10, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: bevacizumab [Avastin] |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall response rate, time to progression, disease control rate, overall survival, tumor necrosis rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
- AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 29 |
| Study Start Date: | February 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab [Avastin]
5mg/kg iv every 2 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00576199 History of Changes |
| Other Study ID Numbers: | ML21358 |
| Study First Received: | December 18, 2007 |
| Last Updated: | August 10, 2012 |
| Health Authority: | Hong Kong: Department of Health |
Additional relevant MeSH terms:
|
Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Bevacizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013