Overview

Lidocaine Infusion in Pancreatic Cancer

Status:
Recruiting

Trial end date:
2022-01-01

Target enrollment:
0

Participant gender:
All

Summary

This study elucidates the effects of the intravenous (IV) lidocaine infusion on the biology of pancreatic circulating tumor cells (CTCs) isolated from patients undergoing robotic pancreatectomy for all types of pancreatic cancer. A prospective randomized controlled double blinded trial design will be used for the proposed study.

Phase:

Early Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Illinois at Chicago

Treatments:

Lidocaine

Criteria

Inclusion Criteria:

1. Has histologically or cytologically confirmed adenocarcinoma of the pancreas that is
considered resectable as well as other types of pancreatic cancer (malignant endocrine
and exocrine tumors)

2. Has measurable disease, defined as at least 1 tumor that fulfills the criteria

3. Patients diagnosed with resectable cancer, but upon initial phase of surgical
exploration found to have metastatic disease

4. Has read, understood and signed the informed consent form (ICF) approved by the
Independent Review Board/Independent Ethics Committee (IRB/IEC)

5. Prior systemic treatments for metastatic disease are permitted, including targeted
therapies, biologic response modifiers, chemotherapy, hormonal therapy, or
investigational therapy.

Exclusion Criteria:

1. Has American Society of Anesthesiologists (ASA) physical status > 3

2. Has hypersensitivity or allergy to amide-linked local anesthetics

3. Has a second or third degree heart block

4. Has severe sinoatrial block

5. Is currently being treated with any of the following class I antiarrhythmic drugs;
quinidine, flecainide, disopyramide, or procainamide

6. Has been treated with amiodarone in the past

7. Has Adams-Stoke syndrome

8. Has Wolff-Parkinson-White syndrome

9. Has a history of blood clots, pulmonary embolism, or deep vein thrombosis unless
controlled by anticoagulant treatment

10. Has a known history of human immunodeficiency virus (HIV) positivity or untreated and
uncontrolled hepatitis B or C