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

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

Detailed Description
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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.

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

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Drug: PEP02


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEP02<br>Liposome Irinotecan | Drug: PEP02<br>* 120 mg/m2, IV infusion for 90 minutes on day 1 of each 21 days as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.<br>* Other names: Liposome irinotecan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate | Survival rate at 3 months | 3-month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase II study, Second line, Pancreatic cancer, Metastatic