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Local Anesthetic
Lidocaine Infusion for Pancreatic Cancer
Phase < 1
Recruiting
Led By Gina E. Votta-Velis, MD PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients diagnosed with resectable cancer, but upon initial phase of surgical exploration found to have metastatic disease
Has measurable disease, defined as at least 1 tumor that fulfills the criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcomes will be evaluated perioperatively
Summary
This trial will investigate whether IV lidocaine affects the behavior of pancreatic CTCs.
Who is the study for?
This trial is for patients with pancreatic cancer that was initially thought to be removable but found to have spread at surgery. They may have had previous treatments like chemo. Participants must understand and sign a consent form, and their cancer should be measurable by certain medical criteria.
What is being tested?
The study is testing the effects of IV lidocaine (a local anesthetic) on circulating tumor cells in patients undergoing robotic surgery for pancreatic cancer. It's a controlled experiment where neither doctors nor patients know who gets lidocaine or a saline placebo.
What are the potential side effects?
While not specified here, common side effects of IV lidocaine can include dizziness, sleepiness, changes in blood pressure, numbness around the mouth, tingling sensations, or even seizures if given too much.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer was thought to be removable but was found to have spread during surgery.
Select...
I have at least one tumor that can be measured.
Select...
My pancreatic cancer is confirmed and can be surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ perioperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~perioperatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Specimen outcome measure.
Upregulation or Downregulation of Gene Expression.
Secondary study objectives
Specimen outcome measure
Side effects data
From 2021 Phase 1 & 2 trial • 26 Patients • NCT0325439443%
Nausea
29%
Dizziness
21%
Headache
14%
Paresthesia
14%
Lightheadedness
7%
Somnolence
7%
Arrhythmia
7%
Blurred vision
7%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + FOLFOX
Lidocaine + FOLFOX
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lidocaine HydrochlorideExperimental Treatment1 Intervention
The IV bolus and infusions of lidocaine to those patients assigned to the lidocaine group will be started in the operating room and will continue until 24 h later. The group receiving the lidocaine infusion will first be administered a 1.0 - 1.5 mg/kg loading infusion over 5 minutes followed by a 1.0 - 1.5 mg/kg/h infusion for 24 h
Group II: Saline Solution for InjectionPlacebo Group1 Intervention
The group receiving the saline infusion will be administered an equivalent volume of saline infused over 5 min followed by a saline infusion at the same flow rate as that used in the lidocaine group for 24 h (1.0 - 1.5 mg/kg/hr)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine Hydrochloride
2022
Completed Phase 4
~2260
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
640 Previous Clinical Trials
1,568,752 Total Patients Enrolled
Gina E. Votta-Velis, MD PhDPrincipal InvestigatorAssociate Professor