Pancreatic Neoplasms
Conditions
Keywords
Phase II study, Second line, Pancreatic cancer, Metastatic
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.
Interventions
DRUGPEP02
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.
Sponsors
PharmaEngine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate | 3-month | Survival rate at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| other efficacy endpoints | 6-8 weeks | objective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response |
| toxicities | 36 months | All adverse events |
| pharmacogenetics | 24 months | UGT1A1 polymorphism |
Countries
Taiwan, United States
Outcome results
None listed