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

Sponsor

PharmaEngine (Industry)

Overall Status

Completed

CT.gov ID

NCT00813163

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

13.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms	Drug: PEP02	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEP02 Liposome Irinotecan	Drug: 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. Other Names: Liposome irinotecan

Arm

Intervention/Treatment

Experimental: PEP02

Liposome Irinotecan

Drug: 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.

Other Names:

Liposome irinotecan

Outcome Measures

Primary Outcome Measures

Survival Rate [3-month]
Survival rate at 3 months

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Cancer Center, UCSF	San Francisco	California	United States	94115
2	National Health Research Institutes/National Chen-Kung Uiversity Hospital	Tainan		Taiwan	704
3	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

PharmaEngine

Investigators

Principal Investigator: Li-Tzong Chen, M.D., National Health Research Institutes, Taiwan
Principal Investigator: Andrew H Ko, M.D., University of California, San Francisco
Principal Investigator: Yu-Lin Lin, M.D., National Taiwan University Hospital