Clinical trial · Interventional
Opioid Growth Factor (OGF) and Gemcitabine: Novel Treatment for Pancreatic Cancer
OGF & Gemcitabine: Novel Treatment for Pancreatic Cancer Phase I, A Safety and Toxicity Study
NCT00783172CI-TRIAL-00034714terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Problems with IRB
Summary
Brief summary (as posted)
It is hypothesized that OGF biotherapy may be safely administered in combination with gemcitabine to individuals with unresectable pancreatic cancer. The study includes two aims, the first is to evaluate the safety and toxicity of the combination of OGF and gemcitabine chemotherapy. The second aim of the trial is to study the efficacy of OGF and gemcitabine when used in combination.
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 |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Opioid Growth Factor (OGF) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OGF & Gemcitabine
- description
- Opioid Growth factor 250 ug/kg IV once a week. Gemcitabine 1000 mg/m2 weekly for 7 out of 8 weeks induction then every 3 out of 4 week cycles.
- interventionNames
- Drug: Gemcitabine
- Biological: Opioid Growth Factor (OGF)
Primary outcomes (1)
- measure
- progression measured with CT scan
- timeFrame
- every 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * unresectable and histological or cytological confirmation of adenocarcinoma of the pancreas and measurable disease by CT scan * patient has not been previously treated for pancreatic cancer Exclusion Criteria: * history of cancer other than pancreatic cancer (excluding resected basal cell skin cancer or curative stage 1 cervical cancer if disease free for 5 years or more) * previous treatment with chemotherapy for pancreatic cancer * uncontrolled cardiovascular disease (congestive heart failure, symptoms of coronary artery disease, cardiac arrhythmias) * suffered from myocardial infarction in preceding 6 months * poorly controlled medical conditions including: asthma, chronic obstructive pulmonary disease, diabetes, seizure disorders, known brain metastases, hepatic or renal failure * pregnant or nursing women * known allergy to gemcitabine
References
Publications (5)
- BACKGROUNDZagon IS, Jaglowski JR, Verderame MF, Smith JP, Leure-Dupree AE, McLaughlin PJ. Combination chemotherapy with gemcitabine and biotherapy with opioid growth factor (OGF) enhances the growth inhibition of pancreatic adenocarcinoma. Cancer Chemother Pharmacol. 2005 Nov;56(5):510-20. doi: 10.1007/s00280-005-1028-x. Epub 2005 Jun 10. PMID 15947928
- 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
- BACKGROUNDZagon IS, Smith JP, McLaughlin PJ. Human pancreatic cancer cell proliferation in tissue culture is tonically inhibited by opioid growth factor. Int J Oncol. 1999 Mar;14(3):577-84. doi: 10.3892/ijo.14.3.577. PMID 10024694
- BACKGROUNDZagon IS, Hytrek SD, Smith JP, McLaughlin PJ. Opioid growth factor (OGF) inhibits human pancreatic cancer transplanted into nude mice. Cancer Lett. 1997 Jan 30;112(2):167-75. doi: 10.1016/s0304-3835(96)04566-1. PMID 9066724
- BACKGROUNDSmith 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