Lidocaine infusion for patients with pancreatic cancer
Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects
This study is testing if giving lidocaine through an IV can change the behavior of cancer cells in the blood of patients with pancreatic cancer who are having surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04048278 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of intravenous lidocaine infusion on circulating tumor cells (CTCs) in patients undergoing robotic pancreatectomy for pancreatic cancer. It aims to determine how lidocaine affects enzymatic activities and pathways in isolated CTCs during the perioperative period. Patients will be randomly assigned to receive either a saline infusion or a lidocaine infusion for 24 hours, with blood samples collected at various times to evaluate the study's objectives.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed resectable pancreatic cancer who are undergoing robotic pancreatectomy.
Not a fit: Patients with severe heart conditions or allergies to amide-linked local anesthetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of pancreatic cancer by potentially reducing the number of circulating tumor cells and their enzymatic activity.
How similar studies have performed: While the use of lidocaine in cancer treatment is being explored, this specific approach targeting pancreatic cancer and CTCs is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- University of Illnois at Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Gina E. Votta-Velis, MD PhD — Associate Professor
- Study coordinator: Alexandra Barabanova, MS
- Email: barabano@uic.edu
- Phone: (312)996-4020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.