A Phase 2 Open-Label Study Of OSI-774 (NSC 718781) In Unresectable Hepatocellular Carcinoma
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
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 ), 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
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
Summarized by Kaplan-Meier curves, from which medians and progression-free survival can be attained.
Time from initiation of therapy until documented disease progression, assessed at 16 weeks
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|