Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma
- Determine the progression-free survival (PFS) of patients with stage III or IV
adenocarcinoma of the pancreas treated with erlotinib hydrochloride as first- or
- Determine the proportion of patients with a radiological response to this drug.
- Determine the overall survival of these patients.
- Determine the effect of this drug on quality of life in these patients.
- Correlate expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin,
fibronectin, and ki67 in baseline tumor blocks and presence of K-ras mutations in
baseline tumor biopsy specimens with response to this drug.
- Correlate smoking status with PFS in patients treated with this drug.
- Collect serum samples before, during, and after therapy for future serum proteomic
studies and for development of profiles of responders to this drug.
OUTLINE: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses
repeat every 21 days for up to 12 months in the absence of disease progression or
Patients complete a questionnaire about their smoking status at baseline. Patients also
complete questionnaires about their quality of life every three weeks during study therapy
and after completion of study therapy.
Blood samples are collected from patients at baseline and periodically during study for
future serum proteomic research and for development of profiles of responders to erlotinib
hydrochloride therapy. Paraffin-embedded tumor tissue from diagnostic tumor biopsies is
assessed at baseline for expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin,
fibronectin, and ki67 by immunohistochemical analysis. Tissue from surgical specimens in
patients with prior resection is assessed for K-ras mutations by K-ras analysis.
After completion of study therapy, patients are followed for at least 6 months.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Renuka Iyer, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|