Lidocaine Infusion in Pancreatic Cancer: Translational Studies in a Preclinical Model And Human Subjects

Who is this study for? Patients with pancreatic cancer
What treatments are being studied? Lidocaine Hydrochloride
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

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

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

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

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

Locations
United States
Illinois
University of Illnois at Chicago
RECRUITING
Chicago
Contact Information
Primary
Alexandra Barabanova, MS
barabano@uic.edu
(312)996-4020
Backup
Gina E. Votta-Velis, MD PhD
barabano@uic.edu
(312)996-4020
Time Frame
Start Date: 2018-11-08
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 46
Treatments
Experimental: Lidocaine Hydrochloride
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
Placebo_comparator: Saline Solution for Injection
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)
Sponsors
Leads: University of Illinois at Chicago

This content was sourced from clinicaltrials.gov