Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer
Recruitment status was Active, not recruiting
The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer|
- Survival Rate [ Time Frame: 3-month ] [ Designated as safety issue: No ]
- other efficacy endpoints such as objective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response [ Designated as safety issue: No ]
- toxicities [ Designated as safety issue: Yes ]
- pharmacogenetics [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||May 2012|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
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 Name: Liposome irinotecan
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.
|United States, California|
|Comprehensive Cancer Center, UCSF|
|San Francisco, California, United States, 94115|
|National Health Research Institutes/National Chen-Kung Uiversity Hospital|
|Tainan, Taiwan, 704|
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|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|