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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Given PO
Correlative studies
Correlative studies
M D Anderson Cancer Center
Houston, Texas, United States
Progression-free survival
Summarized by Kaplan-Meier curves, from which medians and progression-free survival can be attained.
Time frame: Time from initiation of therapy until documented disease progression, assessed at 16 weeks
Objective response rate
Summarized by estimates and standard errors.
Time frame: Up to 4 years
Rate of stable disease
Summarized by estimates and standard errors.
Time frame: Up to 4 years
Duration of stable disease
Summarized by Kaplan-Meier curves, from which medians and overall duration of stable disease can be attained.
Time frame: From the start of the treatment until the criteria for progression are met, assessed up to 4 years
Time to progression
Summarized by Kaplan-Meier curves, from which medians and time to progression can be attained.
Time frame: Up to 4 years
Overall survival
Summarized by Kaplan-Meier curves, from which medians and overall survival can be attained.
Time frame: Up to 4 years
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