Clinical trial · Interventional
Etanercept and Gemcitabine in Patients With Advanced, Chemotherapy Naive Pancreatic Adenocarcinoma
A Phase I/II Study of Etanercept and Gemcitabine in Patients With Advanced Stage and Chemotherapy Naive Pancreatic Adenocarcinoma
NCT00201838CI-TRIAL-00030604completedPhase 1 / Phase 2Results postedClinicalTrials.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)
The aims of this protocol are: 1. To study the safety and tolerability of the combination of etanercept and gemcitabine in patients with advanced pancreatic cancer: 2. To estimate the anti-tumor effect as measured by the proportion of patients free of disease-progression at six months after treatment initiation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etanercept | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients received entanercept 25 mg subcutaneously twice weekly with gemcitabine.
- interventionNames
- Drug: Gemcitabine
- Drug: Etanercept
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients with pancreatic cancer for which treatment with gemcitabine as a single agent is planned will be asked to participate in this trial as a control group.
- interventionNames
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have pathological diagnosis recurring or metastatic Pancreatic Adenocarcinoma * No prior chemotherapy, immunology treatments or hormonal treatments * Measurable disease * Must be \>18 years old * ONLY CONTROL ARM IS OPEN TO ACCRUAL Inclusion Criteria: * Pregnant and nursing mothers. * Psychiatric disorders that would interfere with consent ability. * Patients with known brain or leptomeningeal disease. * Patients with history of myocardial infarction with in six previous months. * Any concurrent illness that would constitute a hazard to participation in study. * Known sensitivity to gemcitabine or etanercept. * Prior treatment with etanercept.
References
Publications (1)
- RESULTWu C, Fernandez SA, Criswell T, Chidiac TA, Guttridge D, Villalona-Calero M, Bekaii-Saab TS. Disrupting cytokine signaling in pancreatic cancer: a phase I/II study of etanercept in combination with gemcitabine in patients with advanced disease. Pancreas. 2013 Jul;42(5):813-8. doi: 10.1097/MPA.0b013e318279b87f. PMID 23429495