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Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT00287222
Recruitment Status : Completed
First Posted : February 6, 2006
Results First Posted : July 15, 2011
Last Update Posted : July 15, 2011
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
University of Arkansas

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Bevacizumab Drug: Erlotinib Phase 2

Detailed Description:
This is a phase II study to assess the proportion of subjects that remain progression-free by the 27th week following the onset of treatment and to assess the efficacy of the combination of Bevacizumab and Erlotinib in prolonging time to progression in subjects with inoperable and metastatic hepatocellular carcinoma. Subjects will be treated with a combination of rhuMAb VEGF (Bevacizumab), in combination with Erlotinib and TTP will be assessed as per RECIST criteria. The disease will be evaluated at base line and every 9 weeks with CT scan/MRI and AFP levels. Subjects will be kept on the study till disease progression (as defined by RECIST criteria) or death.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma
Study Start Date : February 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 - Bevacizumab/Erlotinib
Subjects will be treated with bevacizumab and erlotinib
 Drug: Bevacizumab
15 mg/KG I.V. every 21 days
Other Name: Avastin

Drug: Erlotinib
150 mg orally every day
Other Name: Tarceva


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Who Remained Free of Progression at the 27th Week. [ Time Frame: 27 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • PT/INR < 1.5 X ULN
  • Life expectancy of >3 months
  • Subjects should be able to sign informed consent and be agreeing to comply with therapy and follow up.
  • Negative pregnancy test in women with childbearing potential, within one week prior to initiation of treatment.
  • Fertile men and women must agree to use adequate contraception prior to study entry, for the duration of study participation, and for at least 1 week after therapy.
  • Age >/= 18 years. The agents Bevacizumab and Erlotinib have not been studied in pediatric subjects, thus the doses to be used in this study cannot be assumed to be safe in children.

Exclusion Criteria:

  • 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
  • Urine protein: creatinine ratio >1.0 at screening
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
  • Serious, non-healing wound, ulcer, or bone fracture
  • Inability to comply with study and/or follow-up procedures
  • Gastrointestinal disease resulting in an inability to take oral medication or a requirement for intravenous hyperalimentation.
  • History of significant gastrointestinal bleeding requiring procedural intervention (e.g. variceal banding, TIPS procedure, arterial embolization, topical coagulation therapy) within six months prior to study Day 0.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
  • Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287222


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Arkansas
Genentech, Inc.
Investigators
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Principal Investigator: Rangaswamy Govindarajan, MD University of Arkansas
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rangaswamy Govindarajan, UAMS
ClinicalTrials.gov Identifier: NCT00287222    
Other Study ID Numbers: UARK 2005-13
First Posted: February 6, 2006    Key Record Dates
Results First Posted: July 15, 2011
Last Update Posted: July 15, 2011
Last Verified: June 2011
Keywords provided by University of Arkansas:
Inoperable and Metastatic Hepatocellular Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Bevacizumab
 Erlotinib Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action