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

Phase 2

Completed

Brief Summary: The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
PEP02	PEP02	Liposome Irinotecan

Primary Outcome Measures

Name	Time	Method
Survival Rate	3-month	Survival rate at 3 months

Secondary Outcome Measures

Name	Time	Method
toxicities	36 months	All adverse events
other efficacy endpoints	6-8 weeks	objective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response
pharmacogenetics	24 months	UGT1A1 polymorphism

Locations (3): National Health Research Institutes/National Chen-Kung Uiversity Hospital
🇨🇳
Tainan, Taiwan
National Taiwan University Hospital
🇨🇳
Taipei, Taiwan
Comprehensive Cancer Center, UCSF
🇺🇸
San Francisco, California, United States