Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma

NCT00287222 | Completed Phase 2 Results

• 1 other identifier: UARK 2005-13
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

The primary efficacy endpoint will be the proportion of subjects that remain free of progression at the 27th week following the onset of treatment. Secondary objectives include the subject's time in weeks from treatment onset to documented disease progression as assessed by the RECIST criteria, response rate, median and overall survival, safety and tolerability.

Conditions

Hepatocellular Carcinoma

Keywords

Inoperable and Metastatic Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Remained Free of Progression at the 27th Week.

  27 weeks

Study Arms (1)

1 - Bevacizumab/Erlotinib

EXPERIMENTAL

Subjects will be treated with bevacizumab and erlotinib

Drug: Bevacizumab; Drug: Erlotinib

Interventions

Bevacizumab DRUG

15 mg/KG I.V. every 21 days

Also known as: Avastin

1 - Bevacizumab/Erlotinib

Erlotinib DRUG

150 mg orally every day

Also known as: Tarceva

1 - Bevacizumab/Erlotinib

Eligibility Criteria

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

You may qualify if:

• Subjects should have histologically or cytologically confirmed diagnosis of hepatocellular carcinoma, regardless of biopsy site.
• Subjects with a liver mass and markedly elevated AFP (\>500ng/mL) are eligible.
• Subjects should not be on the liver transplantation schedule
• Subjects can have prior therapy with sorafenib (nexavar) only if the therapy was stopped due to toxicity or allergic reaction soon after starting. Subjects must have been treated for less than two weeks to be eligible.
• Radiation therapy for palliation to the areas outside the site of tumor used for measurements is permitted. If a subject has received radiation therapy to the liver, the subject id eligible if there is a new lesion or if the prior lesion has increased in size.
• Subjects who have recovered from prior surgical procedure
• Performance status of ECOG 0-2
• Measurable or evaluable disease
• Be declared unresectable or not suitable candidates for surgery
• Adequate organ functions
• Serum bilirubin \<3 mg/dl, AST \<5x ULN, ALT \<5XULN
• Serum albumin \>2.5 g/dl
• Serum creatinine \< 2.0 mg/dl
• ANC \>1200 MM3
• Platelet count \>75,000/ml

You may not qualify if:

• Surgically resectable disease
• Subjects with active bacterial infections
• Subjects with brain metastases
• Pregnant women (positive pregnancy test) or lactating
• No other malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the subject has been disease-free for five years.
• Abnormalities of the cornea based on history (e.g. dry eye syndrome, Sjogren's syndrome) or congenital abnormality (e.g. Fuch's dystrophy).
• Current, recent (within 4 weeks of the first infusion of the study), or planned participation in an experimental drug study other than a Genentech-sponsored Bevacizumab/Erlotinib cancer study
• Hepatic encephelopathy (as per treating physician's evaluation)
• Uncontrolled blood Pressure \>150/100 mmHg
• Unstable angina
• NYHA grade II or greater congestive heart failure
• History or myocardial infraction within 6 months
• History of stroke within 6 months
• Clinically significant peripheral vascular disease (clinically significant venous or arterial thrombotic disease).
• Evidence of bleeding diathesis or coagulopathy

Sponsors & Collaborators

• University of Arkansas: lead
• Genentech, Inc.: collaborator

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• Govindarajan R, Siegel E, Makhoul I, Williamson S. Bevacizumab and erlotinib in previously untreated inoperable and metastatic hepatocellular carcinoma. Am J Clin Oncol. 2013 Jun;36(3):254-7. doi: 10.1097/COC.0b013e318248d83f.

  PMID: 22643560 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab; Erlotinib Hydrochloride

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; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Two subjects withdrew consent.

Results Point of Contact

• Title: Sandy Annis
• Organization: University of Arkansas for Medical Sciences

amannis@uams.edu

5016868274

Study Officials

• Rangaswamy Govindarajan, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 3, 2006
• First Posted: February 6, 2006
• Study Start: February 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 15, 2011
• Results First Posted: July 15, 2011

Record last verified: 2011-06

Locations

US (2)