A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer
Gemcitabine monotherapy or a gemcitabine-based combination regimen is the standard first
line therapy for advanced pancreatic cancer. After disease progression, there is no
standard treatment available. In animal studies and a previous phase I trial, PEP02 has
shown anti-tumor activity and preliminary efficacy in pancreatic cancer. In addition, a
phase II study of free-form irinotecan single agent has already shown encouraging activity
as second-line treatment for patients with advanced pancreatic cancer refractory to
gemcitabine. The liposome formulation of PEP02 theoretically has therapeutic advantages
over free-form irinotecan, such as site-specific delivery and extended release of drug.
Hence PEP02 may be able to provide better efficacy than free-form irinotecan.
The primary purpose of this phase II study is to evaluate the activity of PEP02 as a
second-line therapy in patients with metastatic pancreatic cancer failed to gemcitabine
treatment. The primary goal is to measure the 3-month survival rate. An optimal Simon's
2-stage design will be used for this exploratory phase II study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Li-Tzong Chen, M.D.
National Health Research Institutes, Taiwan
United States: Food and Drug Administration
|Comprehensive Cancer Center, UCSF||San Francisco, California 94115|