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Clinical Trial Summary

RATIONALE: Opioid growth factor may stop the growth of pancreatic cancer by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well opioid growth factor works in treating patients with advanced pancreatic cancer that cannot be removed by surgery.


Clinical Trial Description

OBJECTIVES:

Primary

- Determine the growth inhibitory effects of opioid growth factor ([Met^5]-enkephalin) in patients with advanced unresectable pancreatic cancer.

Secondary

- Determine the pharmacokinetics of this drug in these patients.

- Determine the quality of life of patients treated with this drug.

- Determine the pain control, depression, and nutritional status of patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive opioid growth factor ([Met^5]-enkephalin) IV over 45 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 4 weeks during study treatment, and at the completion of study treatment.

Patients are followed weekly for survival.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00109941
Study type Interventional
Source Milton S. Hershey Medical Center
Contact
Status Completed
Phase Phase 2
Start date October 2003
Completion date April 2009

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