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Tyrosine Kinase Inhibitor
Erlotinib for Preventing Liver Cancer
Phase 1 & 2
Waitlist Available
Led By Kenneth K Tanabe
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Individuals with a clinical diagnosis fibrosis or cirrhosis of the liver (no more than Child-Pugh classification A; Child-Pugh-Turcotte score of 6 or less) who have:
- A biopsy of the cirrhotic liver (non-surgical cohort)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of liver resection
Awards & highlights
Study Summary
This trial will test the effectiveness of erlotinib hydrochloride in preventing liver cancer in patients with cirrhosis of the liver.
Who is the study for?
This trial is for adults with liver cirrhosis or fibrosis who are not pregnant, willing to use contraception, and can provide blood samples. They must have a Child-Pugh score of 6 or less, be non-smokers (or willing to quit), and have an ECOG performance status of 0 or 1. People with HIV, those using certain GI tract pH-altering drugs regularly, or those allergic to compounds similar to erlotinib cannot join.Check my eligibility
What is being tested?
The study is testing the best dose of Erlotinib Hydrochloride to prevent liver cancer in patients with liver cirrhosis. It involves taking this medication and monitoring its effects on preventing the development of fibrous tissue that could lead to cancer.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed here, Erlotinib commonly causes rash, diarrhea, appetite loss, fatigue, shortness of breath and coughing. Some people might experience more severe issues like lung problems or liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver condition is mild (Child-Pugh A) with a score of 6 or less.
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I have had a liver biopsy confirming cirrhosis.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am recommended to have liver surgery.
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My liver biopsy showed high levels of phospho-EGFR.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response (at Least a 50% Reduction in Liver Phospho-EGFR Staining)
Secondary outcome measures
Adverse Event Profile
Other outcome measures
Change in Viral Load in Participants With Hepatitis C Virus (HCV)+
Changes in EGF Levels in the Liver
Liver
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Prevention (erlotinib hydrochloride)Experimental Treatment4 Interventions
Patients receive erlotinib hydrochloride PO QD for 7 days (depending on the date of surgery, treatment range may be 5-14 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erlotinib
2011
Completed Phase 4
~2290
Erlotinib Hydrochloride
2010
Completed Phase 2
~2850
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,642 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Kenneth K TanabePrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I regularly use drugs for stomach acid but can stop them for the trial with my doctor's approval.I am not taking medications like rifampicin or phenytoin.I have previously been treated with medications targeting EGFR.I have been diagnosed with HIV.My liver condition is mild (Child-Pugh A) with a score of 6 or less.I had a liver biopsy less than 3 months ago, and the tissue is available for research.I am not pregnant or breastfeeding and agree to use contraception during the study.I am able to undergo medical procedures.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I had a liver biopsy through my skin or jugular vein over a week ago.I have had a liver biopsy confirming cirrhosis.I am fully active or restricted in physically strenuous activity but can do light work.My recent liver biopsy shows no signs of chronic liver conditions.I am recommended to have liver surgery.You have had allergic reactions to drugs similar to erlotinib (Tarceva).You have not taken any other experimental medications within the past 6 months.I am not taking strong medications like ketoconazole or consuming grapefruit.I haven't had a complete biopsy through skin or vein for my condition.I cannot stop my blood thinners for a liver biopsy or surgery.I agree to provide tissue samples from my liver surgery or biopsy for study.My liver biopsy showed high levels of phospho-EGFR.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (erlotinib hydrochloride)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what locales are the research activities of this inquiry being conducted?
"Presently, 6 medical centres are taking part in this research endeavor. These include Cleveland Clinic Foundation and Mayo Clinic (in Rochester), as well as Case Western Reserve University (in Jacksonville). Other sites also exist within the United States."
Answered by AI
Is there an ongoing call for participants in this experiment?
"Data on clinicaltrials.gov confirms that this trial is not currently enrolling participants, as the last update was made in February of 2022. However, there are still 3093 other studies recruiting patients at present."
Answered by AI
For which conditions is Erlotinib typically prescribed?
"Erlotinib is a medication suitable for treating pancreatic metastatic cancer, carcinoma, and those who have not been treated with any other therapies."
Answered by AI
What is the current participant count for this trial?
"As of February 24th, 2022 this medical study is no longer actively recruiting. Originally posted in November 2014 and last updated over 6 years later, the trial has ceased its search for participants. Nevertheless, there are 3044 trials looking to recruit patients with carcinoma and 49 studies actively searching for individuals taking Erlotinib medication."
Answered by AI
Are there any published scholarly works that detail the effects of Erlotinib?
"Initially, erlotinib was studied at Mayo Clinic's Rochester branch in 2002. Currently, there are 1058 completed studies and 49 active trials taking place - the majority of which occur in Cleveland, Ohio."
Answered by AI
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