Spots Global Cancer Trial Database for Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

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Trial Identification

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

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

Study ID: NCT00109941

Conditions

Pancreatic Cancer

Interventions

opioid growth factor

metenkephalin, OGF-opioid growth factor

Study Description

Brief 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.