Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer

A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer

The purpose of this study is to see the effect of PEP02 in the treatment of 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.

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
• Metastatic disease
• Documented disease progression after treatment with 1 line of prior gemcitabine-based regimen
• Karnofsky performance status equal or more than 70

Exclusion Criteria:

• With active CNS metastases
• With clinically significant gastrointestinal disorder (e.g., bleeding, inflammation, occlusion, or diarrhea > grade 1)
• Major surgery or radiotherapy within 4 weeks
• Prior participation in any investigational drug study within 4 weeks
• With prior irinotecan treatment