Skip to Main Content

An official website of the United States government

Government Funding Lapse

Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit  cc.nih.gov. Updates regarding government operating status and resumption of normal operations can be found at OPM.gov.

View 0 Studies Requested

Browse EPPT > MAY2013-02-02

Pilot Study of EGFR Inhibition with Erlotinib in Cirrhosis to Inhibit Fibrogenesis and Prevent Hepatocellular Carcinoma

Eligibility Criteria


Inclusion Criteria

  • Pre-Registration Inclusion:
    • Individuals with a clinical diagnosis fibrosis or cirrhosis of the liver:
      • an indication for surgical liver resection, OR
      • a clinical liver biopsy (with research tissue specimens available for analysis) ≤ 3 months prior to pre-registration.
    • Age ≥18 years.
    • Willingness to discontinue smoking during the study two weeks prior to beginning the study and willingness to not smoke while taking study medication.
    • Not pregnant or breast feeding.
    • Willingness to use adequate contraception to avoid pregnancy or impregnation until 2 weeks after discontinuing study agent.
    • Willingness to provide mandatory blood specimens as specified in the protocol.
    • Able to undergo:
      • Percutaneous or transjugular biopsy of cirrhotic liver at least 7 days prior to liver resection Surgical cohort), OR
      • A biopsy of the cirrhotic liver (Non-surgical cohort).
    • Willingness to authorize collection of tissue from surgically-resected liver or clinical liver biopsy for analyses specified in the protocol.
    • Ability to understand and the willingness to sign a written informed consent document.
  • Registration Inclusion:
    • ECOG performance status 0 or 1.
    • Participants must have normal organ and marrow function as defined below:
      • INR ≤ 1.5
      • Platelets ≥ 50 B/L (109/L)
      • Total bilirubin ≤ 3 × institutional ULN
      • AST (SGOT) and ALT (SGPT) ≤ 5 × institutional ULN
      • Creatinine ≤ 1.5 × institutional ULN
    • Non-surgical cohort only:
      • Positive phospho-EGFR assessment
    • Pre-Intervention biopsy sample collected.

Exclusion Criteria

  • Pre-Registration Exclusion:
    • Any prior treatment with erlotinib or other agent whose primary mechanism of action is known to inhibit EGFR.
    • Participants with a known diagnosis of HIV.
    • Participants who regularly (≥ 2 times per week) use drugs that alter the pH of the GI tract, such as proton pump inhibitors (PPI) and antacids. Exceptions: Individuals who use prescription PPIs and have approval from their primary health care provider to discontinue for the duration of clinical trial participation may be enrolled.
    • Uncontrolled intercurrent illness.
    • Use of potent CYP3A4 inhibitors or grapefruit juice.
    • Use of CYP3A4 inducers or St. John's Wort.
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib (Tarceva™).
    • Participants who cannot have their warfarin, Lovenox, Plavix, or other comparable medications held for percutaneous or transjugular liver biopsy and surgery if so indicated.
    • Non-surgical cohort only: Pathology report from clinical liver biopsy (≤ 3 months prior to pre-registration) demonstrates no histologic abnormalities associated with chronic hepatitis, steatohepatitis, fibrosis, or cirrhosis.
  • Registration Exclusion:
    • Receiving any other investigational agents ≤6 months prior to Registration.
    • Surgical cohort (Cohort A only): Percutaneous or transjugular biopsy incomplete or not performed.