Phase II trial to study the effectiveness of erlotinib in treating patients who have unresectable liver, bile duct, or gallbladder cancer. Biological therapies such as erlotinib may interfere with the growth of cancer cells and slow the growth of the tumor.
PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with unresectable hepatocellular or biliary carcinoma treated with OSI-774 who are progression-free at 24 weeks. SECONDARY OBJECTIVES: I. To evaluate the toxicity profile of this treatment in each of the patient groups. II. To evaluate the objective response rate of patients with hepatocellular or biliary carcinoma treated with OSI-774. III. To evaluate overall and progression-free survival. IV. To assess the EGFR protein levels and explore their association with clinical outcome. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to cancer type (hepatocellular vs biliary). Patients receive oral erlotinib once daily. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for up to 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Given orally
Correlative studies
Mayo Clinic
Rochester, Minnesota, United States
Proportion of patients who are progression-free at 24 weeks
Confidence intervals for the true PFR will be calculated using the methods of Duffy-Santner.
Time frame: At 24 weeks
Objective response, defined by the RECIST criteria in terms of tumor/lesion size and change
Time frame: Up to 3 years
Overall survival
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to death due to any cause, assessed up to 3 years
Time to disease progression
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to documentation of disease progression, assessed up to 3 years
EGFR protein levels
We will evaluate these EGFR protein levels and explore their association with clinical outcome.
Time frame: Baseline
Overall response rate in EGFR positive patients
Analyses will be done independently on patients from each patient group. Corresponding 95% confidence intervals will also be calculated.
Time frame: Up to 3 years
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