Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery (OGF)
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
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
Sites / Locations
- Penn State Cancer Institute at Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Experimental
metenkephalin, OGF-opioid growth factor
DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes