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

PharmaEngine

Status and phase

Completed

Phase 2

Conditions

Pancreatic Neoplasms

Treatments

Drug: PEP02

Study type

Interventional

Funder types

Industry

Identifiers

NCT00813163

PEP0208

Details and patient eligibility

About

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

Full 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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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