Phase 2
N=38
Etanercept and Gemcitabine in Patients With Advanced, Chemotherapy Naive Pancreatic Adenocarcinoma
Pancreatic Neoplasms · Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00201838 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation — 28; 14 percent of patients with PFS
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gemcitabine (Drug); Etanercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Oct 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-tumor Effect as Measured by the Proportion of Patients Free of Disease-progression at Six Months After Treatment Initiation |
28; 14 | — |
| SECONDARY Number of Patients With Response |
12; 17; 32; 50 | — |
| SECONDARY Percentage of Patients With Clinical Benefit Response |
33; 0 | — |
| SECONDARY Median Overall Survival Rates for Patients |
5.43; 8.1 | — |
| SECONDARY Serial Levels of TNF (Tumor Necrosis Factor) and Other Inflammatory Cytokines |
28.04; 26.85; 16.2; 13.07; 6.03; 4.38 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00201838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.