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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
OGF given in saline iv 250 ug/kg weekly
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Survival
Response (progressive disease, stable disease, partial response, complete response)
Tumor size
Quality of life
Depression
Opioid growth factor markers
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.