Clinical trial NCT00813163: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Keywords: Phase II study
Second line
Pancreatic cancer
Metastatic
Lead sponsor: PharmaEngine
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Survival Rate
timeFrame: 3-month
Secondary outcomes:
measure: other efficacy endpoints
timeFrame: 6-8 weeks
measure: toxicities
timeFrame: 36 months
measure: pharmacogenetics
timeFrame: 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Comprehensive Cancer Center, UCSF
state: California
city: Tainan
country: Taiwan
facility: National Health Research Institutes/National Chen-Kung Uiversity Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Health Research Institutes, Taiwan
name: Li-Tzong Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Andrew H Ko, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Yu-Lin Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.