Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II
- Determine the growth inhibitory effects of opioid growth factor ([Met^5]-enkephalin) in
patients with advanced unresectable pancreatic cancer.
- 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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Jill P. Smith, MD
Milton S. Hershey Medical Center
United States: Food and Drug Administration
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|