A Study of Erlotinib as a Prevention in Trisomy 7 Positive Primary Sclerosing Cholangitis

Overview

About this study

Primary sclerosing cholangitis is a chronic inflammation of the bile ducts of unknown cause and eventually results in cirrhosis of the liver. These patients are at increased risk for the development of cancer rising from bile duct tissue. Chromosomal abnormalities of the bile duct tissue, particularly trisomy 7 (i.e. three copies of chromosome 7) can be detected in biopsy samples. Erlotinib (Tarceva) is a human EGFR type 1 tyrosine kinase inhibitor and offers greater survival benefit to EGFR positive patients. This study will assist in determining the safety and tolerability of Tarceva in patients who have primary sclerosing cholangitis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Male or female patients
  • Age > 18 years 
  • Able to provide written informed consent
  • Diagnosis of Primary Sclerosing Cholangitis
  • Scheduled for an ERCP as part of their clinical care
  • Diagnosed with trisomy 7 on cytologic testing
  • Willingness to utilize adequate contraception from screening to at least one month after the trial
    • If female, postmenopausal for at least 6 months or using contraceptive pill
    • For both females and males, surgically sterile, or using two forms of barrier contraception

Exclusion Criteria

  • Cholangiocarcinoma, hepatocellular carcinoma, pancreatic adenocarcinoma or other malignancy ≤3 years of registration
  • Other liver disease as determined by standard clinical, serological, imaging or histological criteria
  • Secondary cause of sclerosing cholangitis (IgG cholangiopathy, autoimmune, post-surgical biliary stricture, radiation, human immunodeficiency syndrome)
  • Cholestasis with a bilirubin of > 1.6 mg/dl (normal range 0.1 - 1.0 mg/dL)
  • Decompensated cirrhosis, Child-Pugh Class B or C
  • Child A cirrhosis with portal hypertension (i.e., splenomegaly, esophageal or gastric varices, or platelet count < 100,000/µl [normal range: 150 - 450 x 103/µL])
  • Transaminase (AST [norm.: 8-48 U/L], ALT [norm.: 7-55 U/L]) elevation of more than three times the upper limit of the normal range
  • Pregnancy
  • Nursing mothers
  • Uncontrolled intercurrent illness
  • Concurrent administration of CYP3A modulators, Antiepileptics, Rifampin, St. Johns wort, Ketoconazole, protonpump-inhibitors
  • Men or women unwilling to employ adequate contraception
  • Abnormalities of the cornea by history
  • Moderate diarrhea defined as defecation frequency of equal or more than 4/d for those with their colon, equal or more than 8/d for patients with a pouch, and high ostomy output with those with ostomy
  • Known interstitial lung disease

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Gregory Gores, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20312129

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