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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
PharmaEngine
ClinicalTrials.gov Identifier:
NCT00813163
First received: December 18, 2008
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Pancreatic Neoplasms
 Drug: PEP02
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of PEP02 as a Second Line Therapy for Patients With Metastatic Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PharmaEngine:

Primary Outcome Measures:
  • Survival Rate [ Time Frame: 3-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • other efficacy endpoints such as objective tumor response, PFS, duration of response, overall survival, tumor marker response of CA19-9, clinical benefit response [ Designated as safety issue: No ]
  • toxicities [ Designated as safety issue: Yes ]
  • pharmacogenetics [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: May 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813163

Locations
United States, California
Comprehensive Cancer Center, UCSF
San Francisco, California, United States, 94115
Taiwan
National Health Research Institutes/National Chen-Kung Uiversity Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
PharmaEngine
Investigators
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
  More Information

No publications provided

Responsible Party: Erica Wang/Senior Manager, Clinical Research, PharmaEngine
ClinicalTrials.gov Identifier: NCT00813163     History of Changes
Other Study ID Numbers: PEP0208
Study First Received: December 18, 2008
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by PharmaEngine:
Phase II study
Second line
Pancreatic cancer
Metastatic

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013