A Phase II Study Of OSI-774 In Metastatic Colorectal Cancer
I. Determine the efficacy of erlotinib, in terms of response rate and duration of stable
disease, in patients with recurrent or metastatic colorectal cancer.
II. Determine the toxicity of this drug in these patients. III. Determine the time to
progression and response duration in patients treated with this drug.
IV. Determine the relationships between clinical, pharmacokinetic, and pharmacodynamic
effects of this drug in these patients.
V. Correlate baseline and post-treatment levels of epidermal growth factor receptor, its
downstream signaling components, markers of angiogenesis, and apoptosis in tumor and skin
biopsies with clinical outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence
of disease progression or unacceptable toxicity. Patients with a complete response (CR)
receive 2 additional courses after CR is confirmed.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4-8
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response or disease stabilization
Up to 5 years
Princess Margaret Hospital Phase 2 Consortium
United States: Food and Drug Administration