Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery (OGF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00109941|
Recruitment Status : Completed
First Posted : May 4, 2005
Last Update Posted : May 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Biological: opioid growth factor Biological: metenkephalin, OGF-opioid growth factor||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||April 2009|
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 peptide
Biological: metenkephalin, OGF-opioid growth factor
OGF given in saline iv 250 ug/kg weekly
Other Name: opioid growth factor
- Response (progressive disease, stable disease, partial response, complete response)
- Tumor size
- Quality of life
- Opioid growth factor markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|