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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813163
• Other study ID #: PEP0208
• Status: Completed
• Phase: Phase 2
• Start date: January 2009
• Est. completion date: July 2012

Study information

• Verified date: August 2019
• Source: PharmaEngine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Health Research Institutes/National Chen-Kung Uiversity Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
United States	Comprehensive Cancer Center, UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
PharmaEngine

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Rate	Survival rate at 3 months	3-month
Secondary	other efficacy endpoints	objective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response	6-8 weeks
Secondary	toxicities	All adverse events	36 months
Secondary	pharmacogenetics	UGT1A1 polymorphism	24 months