An Open Label Pilot Trial of Erlotinib (Tarceva) in Primary Sclerosing Cholangitis With Trisomy 7
- Male or female patients > 18 years of age, 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 (if female, evidenced by being
postmenopausal for at least 6 months or using contraceptive pill; for both females
and males, being surgically sterile, or using two forms of barrier contraception)
from screening to at least one month after the trial.
- Cholangiocarcinoma, hepatocellular carcinoma, pancreatic adenocarcinoma or other
malignancy <=3 years of registration.
- Other liver disease as determined by standard clinical, serological, imaging or
- 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.
- 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