A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Neoplasms
Trial Information
A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Survival Rate
Outcome Time Frame:
3-month
Safety Issue:
No
Principal Investigator
Li-Tzong Chen, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Health Research Institutes, Taiwan
Authority:
United States: Food and Drug Administration
Study ID:
PEP0208
NCT ID:
NCT00813163
Start Date:
January 2009
Completion Date:
May 2012
Related Keywords:
- Pancreatic Neoplasms
- Phase II study
- Second line
- Pancreatic cancer
- Metastatic
- Neoplasms
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Comprehensive Cancer Center, UCSF | San Francisco, California 94115 |
