Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery (OGF)
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.
|Pancreatic Cancer||Biological: opioid growth factor Biological: metenkephalin, OGF-opioid growth factor||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II|
- Response (progressive disease, stable disease, partial response, complete response)
- Tumor size
- Quality of life
- Opioid growth factor markers
|Study Start Date:||October 2003|
|Study Completion Date:||April 2009|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Experimental: metenkephalin, OGF-opioid growth factor
DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes
Biological: opioid growth factor
OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
Other Name: Opioid growth factor or OGF is a 5 amino acid peptideBiological: metenkephalin, OGF-opioid growth factor
OGF given in saline iv 250 ug/kg weekly
Other Name: opioid growth factor
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109941
|United States, Pennsylvania|
|Penn State Cancer Institute at Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|Study Chair:||Jill P. Smith, MD||Milton S. Hershey Medical Center|