Erlotinib Hydrochloride in Preventing Liver Cancer in Patients With Cirrhosis of the Liver Undergoing Surgery

Description

This pilot clinical trial studies the best dose of erlotinib hydrochloride and to see how well it works in preventing liver cancer in patients with scarring (cirrhosis) of the liver undergoing surgery. Erlotinib hydrochloride may help to inhibit the development of fibrous tissue and prevent liver cancer from forming in patients with cirrhosis of the liver.

Study Start Date

November 2014

Estimated Completion Date

January 2018

Interventions

  • Other: quality-of-life assessment
  • Other: Laboratory Biomarker Analysis
  • Drug: Erlotinib Hydrochloride
  • Other: laboratory biomarker analysis
  • Other: Quality-of-Life Assessment
  • Drug: erlotinib hydrochloride

Specialties

  • Surgery: Hernia/GI
  • Gastroenterology: GI Oncology,Hepatology
  • Oncology: GI Oncology

MeSH Terms

  • Liver Neoplasms
  • erlotinib hydrochloride

Study ID

National Cancer Institute (NCI) -- NCI-2014-02170

Status

Unknown

Trial ID

NCT02273362

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

45

Sponsor

National Cancer Institute (NCI)

Inclusion Criteria

  • PRE-REGISTRATION INCLUSION:
  • 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 an indication for surgical liver resection
  • 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
  • women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control abstinence) prior to study entry and for the duration of study participation should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
  • 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 a percutaneous biopsy of cirrhotic liver at least 7 days prior to liver resection
  • Willingness to authorize collection of tissue from surgically resected liver for analyses specified in the protocol
  • Ability to understand and the willingness to sign a written informed consent document
  • REGISTRATION INCLUSION:
  • International normalized ratio (INR) =< 1.5
  • Platelets >= 50 B/L (10^9/L)
  • Total bilirubin =< 3 × institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 × institutional ULN
  • Creatinine =< 1.5 × institutional ULN

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 human immunodeficiency virus (HIV)
  • Note: an HIV screening test does not have to be performed to evaluate this criterion
  • Participants who regularly (>= 2 times per week) use drugs that alter the pH of the gastrointestinal (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 an alternate drug to control gastroesophageal reflux disease (GERD)/peptic ulcer disease (PUD) symptoms will be suggested
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
  • Use of potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors, such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice
  • Use of CYP3A4 inducers such as rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, and 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 liver biopsy and surgery
  • REGISTRATION EXCLUSION:
  • Receiving any other investigational agents =< 6 months prior to registration
  • Percutaneous biopsy incomplete or not performed

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Massachusetts General Hospital Cancer Center - Boston, Massachusetts 2.8 miles Kenneth K Tanabe 617-724-3868 ktanabe@partners.org
Mount Sinai Medical Center - New York, New York 183.2 miles Myron E Schwartz 212-659-8084 Myron.schwartz@mountsinai.org
Case Western Reserve University - Cleveland, Ohio 544.0 miles Christopher T Siegel 216-844-0489 Christopher.siegel@UHhospitals.org
Indiana UniversityMelvin and Bren Simon Cancer Center - Indianapolis, Indiana 805.0 miles Paul Y Kwo 317-274-3090 pkwo@iu.edu
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Paul J Limburg 507-284-2511 limburg.paul@mayo.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.