Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer
Primary Purpose
Pancreatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PEP02
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Phase II study, Second line, Pancreatic cancer, Metastatic
Eligibility Criteria
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
Sites / Locations
- Comprehensive Cancer Center, UCSF
- National Health Research Institutes/National Chen-Kung Uiversity Hospital
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEP02
Arm Description
Liposome Irinotecan
Outcomes
Primary Outcome Measures
Survival Rate
Survival rate at 3 months
Secondary Outcome Measures
other efficacy endpoints
objective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response
toxicities
All adverse events
pharmacogenetics
UGT1A1 polymorphism
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00813163
Brief Title
Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer
Official Title
A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaEngine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms
Keywords
Phase II study, Second line, Pancreatic cancer, Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEP02
Arm Type
Experimental
Arm Description
Liposome Irinotecan
Intervention Type
Drug
Intervention Name(s)
PEP02
Other Intervention Name(s)
Liposome irinotecan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival Rate
Description
Survival rate at 3 months
Time Frame
3-month
Secondary Outcome Measure Information:
Title
other efficacy endpoints
Description
objective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response
Time Frame
6-8 weeks
Title
toxicities
Description
All adverse events
Time Frame
36 months
Title
pharmacogenetics
Description
UGT1A1 polymorphism
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Tzong Chen, M.D.
Organizational Affiliation
National Health Research Institutes, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew H Ko, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yu-Lin Lin, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center, UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
National Health Research Institutes/National Chen-Kung Uiversity Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23880820
Citation
Ko AH, Tempero MA, Shan YS, Su WC, Lin YL, Dito E, Ong A, Wang YW, Yeh CG, Chen LT. A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer. Br J Cancer. 2013 Aug 20;109(4):920-5. doi: 10.1038/bjc.2013.408. Epub 2013 Jul 23.
Results Reference
derived
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Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer
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