Advanced Adult Primary Liver Cancer Clinical Trial
Official title:
A Phase 2 Open-Label Study Of OSI-774 (NSC 718781) In Unresectable Hepatocellular Carcinoma
Phase II trial to study the effectiveness of erlotinib in treating patients who have liver cancer that cannot be surgically removed. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PRIMARY OBJECTIVES:
I. To assess progression-free survival (PFS) measured at 16 weeks following initiation of
once daily continuous oral therapy with OSI-774 in patients with unresectable hepatocellular
carcinoma.
SECONDARY OBJECTIVES:
I. To assess objective response rate, rate and duration of stable disease, time to
progression, median and overall survival in this patient population, and any changes in
tumor perfusion based on functional CT imaging.
II. To correlate response with patient characteristics including: age, disease stage (TNM,
Okuda [6]), viral hepatitis status, pathologic grade of cirrhosis, Childs-Pugh status,
Performance Status, serum values of: alpha feto-protein, bilirubin, transaminases, albumin;
EGFR expression score by IHC; and development of skin rash during therapy.
III. To determine the pharmacokinetic and pharmacodynamic profile of OSI-774 in this patient
population.
IV. To determine the safety and tolerability of OSI-774 in this patient population.
OUTLINE: Patients are stratified according to epidermal growth factor receptor expression
(low, 0-1+ vs high, 2-3+).
Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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