NCT00109941

Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	opioid growth factor	OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
BIOLOGICAL	metenkephalin, OGF-opioid growth factor	OGF given in saline iv 250 ug/kg weekly

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-09-01
• Completion: 2009-04-01
• First posted: 2005-05-04
• Last updated: 2018-09-06

Locations

1 site across 1 country: United States