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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-07-31

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.

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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.

Conditions

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Pancreatic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEP02

Liposome Irinotecan

Group Type EXPERIMENTAL

PEP02

Intervention Type DRUG

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.

Interventions

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PEP02

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.

Intervention Type DRUG

Other Intervention Names

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Liposome irinotecan

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No