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A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Neoplasms

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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, UCSFSan Francisco, California  94115