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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Genentech |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00242502 |
Purpose
The primary objective will be to assess progression-free survival (PFS) measured at 16 weeks following initiation of therapy with the combination of Avastin and erlotinib in patients with unresectable hepatocellular carcinoma (HCC). Progression-free survival is defined as the time from initiation of therapy until documented disease progression or death.
Secondary objectives include: response rate, median and overall survival, toxicity and tolerability, and to ascertain whether there is any correlation of response with prior treatment status and underlying HCC risk factor(s).
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma Liver Cancer |
Drug: Bevacizumab (Avastin) Drug: Erlotinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of the Combination of Bevacizumab and Erlotinib in Patients With Unresectable Hepatocellular Carcinoma |
| Enrollment: | 62 |
| Study Start Date: | October 2005 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bevacizumab + Erlotinib
Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
|
Drug: Bevacizumab (Avastin)
10 mg/kg IV every 14 days, repeat cycle every 28 days
Other Names:
Drug: Erlotinib
150 mg orally every day continuous dosing, repeat cycle every 28 days
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Ahmed Kaseb, M.D. | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00242502 History of Changes |
| Other Study ID Numbers: | 2004-0874 |
| Study First Received: | October 18, 2005 |
| Last Updated: | December 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Hepatocellular Carcinoma Liver Cancer Bevacizumab Anti-VEGF monoclonal antibody rhuMAb-VEGF |
Erlotinib Hydrochloride OSI-774 Tarceva Erlotinib Avastin |
|
Carcinoma Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma Antibodies Antibodies, Monoclonal Bevacizumab |
Erlotinib Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |