Phase II Trial of ISIS 2503, an Antisense Inhibitor of H-Ras, in Patients With Advanced Pancreatic Cancer
OBJECTIVES: I. Determine the response rate and time to progression in patients with advanced
adenocarcinoma of the pancreas who are treated with ISIS 2503. II. Determine the duration of
response in these patients receiving this regimen. III. Characterize the safety profile of
ISIS 2503 at the recommended phase II dose and schedule in these patients.
OUTLINE: Patients receive ISIS 2503 IV continuously for 14 days. Treatment continues every
21 days for a minimum of 3 courses in the absence of unacceptable toxicity or disease
PROJECTED ACCRUAL: A total of 14-27 patients will be accrued for this study within 12
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary outcome measure of this study is to estimate the response rate and observe the time to tumor progression of the patients treated on this study.
James A. Posey, MD
University of Alabama at Birmingham
United States: Federal Government
|University of Alabama Comprehensive Cancer Center||Birmingham, Alabama 35294|
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|