A Dose-Finding, Safety, And Pharmacokinetic Study Of The Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor OSI-774 (NSC 718781) In Patients With Unresectable Hepatocellular Carcinoma And Moderate Hepatic Dysfunction
I. Establish the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of OSI-774 in
patients with unresectable hepatocellular carcinoma (HCC) with moderate liver dysfunction.
II. Establish the pharmacokinetic and pharmacodynamic profile of OSI-774 in HCC patients
with moderate liver dysfunction.
I. Assess possible anti-tumor effects of OSI-774 in patients with advanced hepatocellular
carcinoma in terms of partial response (PR) and complete response (CR) as assessed by tumor
shrinkage by RECIST criteria.
OUTLINE: This is a dose-escalation study.
Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity and maximum tolerated dose as measured by NCI CTCAE v3.0 continuously
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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