Clinical trial · Interventional
Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II
NCT00109941CI-TRIAL-00034729OGFcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metenkephalin, OGF-opioid growth factor | Biological | — | UNRESOLVED |
| opioid growth factor | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- metenkephalin, OGF-opioid growth factor
- description
- DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes
- interventionNames
- Biological: opioid growth factor
- Biological: metenkephalin, OGF-opioid growth factor
Primary outcomes (1)
- measure
- Survival
Secondary outcomes (5)
- measure
- Response (progressive disease, stable disease, partial response, complete response)
- measure
- Tumor size
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDSmith JP, Conter RL, Bingaman SI, Harvey HA, Mauger DT, Ahmad M, Demers LM, Stanley WB, McLaughlin PJ, Zagon IS. Treatment of advanced pancreatic cancer with opioid growth factor: phase I. Anticancer Drugs. 2004 Mar;15(3):203-9. doi: 10.1097/00001813-200403000-00003. PMID 15014352
- RESULTSmith JP, Bingaman SI, Mauger DT, Harvey HH, Demers LM, Zagon IS. Opioid growth factor improves clinical benefit and survival in patients with advanced pancreatic cancer. Open Access J Clin Trials. 2010 Mar 1;2010(2):37-48. doi: 10.2147/oajct.s8270. PMID 20890374