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Study of PEP02 as a Second Line Therapy for Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00813163
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : September 5, 2019
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to see the effect of PEP02 in the treatment of metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: PEP02 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer
Study Start Date : January 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Irinotecan

Arm Intervention/treatment
Experimental: PEP02
Liposome Irinotecan
Drug: PEP02

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

Primary Outcome Measures :
  1. Survival Rate [ Time Frame: 3-month ]
    Survival rate at 3 months

Secondary Outcome Measures :
  1. other efficacy endpoints [ Time Frame: 6-8 weeks ]
    objective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response

  2. toxicities [ Time Frame: 36 months ]
    All adverse events

  3. pharmacogenetics [ Time Frame: 24 months ]
    UGT1A1 polymorphism

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00813163

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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
Sponsors and Collaborators
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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: PharmaEngine Identifier: NCT00813163     History of Changes
Other Study ID Numbers: PEP0208
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: August 2019
Keywords provided by PharmaEngine:
Phase II study
Second line
Pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents