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

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, OR
• A clinical liver biopsy (with research tissue specimens available for analysis) = = 50 B/L (10^9/L)
• Total bilirubin = = 100 stained pixels) from tissue obtained from previous clinical liver biopsy
• 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 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 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 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