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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 below

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My cancer was thought to be removable but was found to have spread during surgery.

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I have at least one tumor that can be measured.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and perioperatively for reporting.

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 • NCT03254394

43%

Nausea

29%

Dizziness

21%

Headache

14%

Paresthesia

14%

Lightheadedness

Somnolence

Arrhythmia

Blurred vision

Itching

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met