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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: opioid growth factor
* Biological: metenkephalin, OGF-opioid growth factor


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Diagnosis of pancreatic cancer Advanced, unresectable disease Must have failed OR refused prior standard chemotherapy (e.g., gemcitabine or fluorouracil) for pancreatic cancer Measurable disease by radiography Age Over 18 Performance status Karnofsky 50-100% Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 WBC ≥ 3,500/mm^3 Hemoglobin ≥ 8.5 g/dL Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 4.0 mg/dL (stents allowed) PT or INR ≤ 2 seconds over control OR ≤ 1.8 (unless on warfarin) renal & metabolic BUN ≤ 30 mg/dL (hydrated) Creatinine ≤ 2.0 mg/dL Sodium ≥ 130 mmol/L Potassium ≥ 3.2 mmol/L Glucose 60-300 mg/dL Pulse 60-110 beats/minute Systolic blood pressure 90-170 mm Hg Exclusion Criteria No primary CNS tumors or known brain metastases Cardiovascular - congestive heart failure symptoms of coronary artery disease cardiac arrhythmia poorly controlled hypertension myocardial infarction within the past year abnormal EKG asthma hronic obstructive pulmonary disease pregnant or nursing Fertile patients must use effective contraception serious infection requiring antibiotics within the past 2 weeks poorly controlled diabetes seizure disorders fever > 37.8° C other malignancy within the past 5 years concurrent chemotherapy concurrent oral steroids concurrent radiotherapy Surgery within 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metenkephalin, OGF-opioid growth factor<br>DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes | Biological: opioid growth factor<br>* OGF was administered in saline at 250 ug/kg intravenously over 45 minutes<br>* Other names: Opioid growth factor or OGF is a 5 amino acid peptide;Biological: metenkephalin, OGF-opioid growth factor<br>* OGF given in saline iv 250 ug/kg weekly<br>* Other names: opioid growth factor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response (progressive disease, stable disease, partial response, complete response) |  |  | 
| Tumor size |  |  | 
| Quality of life |  |  | 
| Depression |  |  | 
| Opioid growth factor markers |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer