Study of PEP02 as a Second Line Therapy for 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|
|Study Completion Date:||July 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813163
|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|