Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Sponsor

University of Louisville (Other)

Overall Status

Recruiting

CT.gov ID

NCT03484299

Collaborator

(none)

Enrollment

Location

Arm

67.1

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer	Procedure: Irreversible Electroporation (IRE) Drug: Gemcitabine Drug: FOLFIRINOX	Phase 1

Detailed Description

Phase II study in which all patients undergoing IRE for the treatment of locally advanced pancreatic carcinoma will receive either FOLFIRINOX or gemcitabine as peri-ablation treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

All subjects undergoing IRE will receive treatment with either FOLFIRINOX or gemcitabine (based on which regimen was received prior to IRE)All subjects undergoing IRE will receive treatment with either FOLFIRINOX or gemcitabine (based on which regimen was received prior to IRE)

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma

Actual Study Start Date :

May 30, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Treatment Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)	Procedure: Irreversible Electroporation (IRE) Non-thermal ablation of tumor Drug: Gemcitabine 25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled Drug: FOLFIRINOX 25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled

Arm

Intervention/Treatment

Other: Treatment

Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE)

Procedure: Irreversible Electroporation (IRE)

Non-thermal ablation of tumor

Drug: Gemcitabine

25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled

Drug: FOLFIRINOX

25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled

Outcome Measures

Primary Outcome Measures

Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability) [Time from first dose until subject has reached 90 days post last active study treatment]
Adverse and Serious Adverse events will be collected and analyzed

Secondary Outcome Measures

Progression free survival [Time from first dose date to first date of confirmed disease progression, assessed for 90 days]
Triphase CT scan will be performed within one month of IRE procedure. Triphase CT scans will then be obtained every 3 months to check disease status.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

greater than or equal to 18 years of age
diagnosed with stage III pancreatic cancer
tumor is measurable
GFR > mL/min/1.73m2
willing and able to comply with protocol requirements
AST/ALT >3 times upper limit of normal
stable surgical post-operative course as defined by operative surgeon

Exclusion Criteria:

participating in another clinical trial for the treatment of cancer at the time of screening
pregnant or currently breast feeding
have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure
have non-removable implants with metal parts within 1 cm of the target lesion
had a myocardial infarction within 3 months prior to enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

University of Louisville

Investigators

Principal Investigator: Robert Martin, MD, PhD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert C. Martin, Principal Investigator, University of Louisville

ClinicalTrials.gov Identifier:

NCT03484299

Other Study ID Numbers:

17.0529

First Posted:

Mar 30, 2018

Last Update Posted:

Oct 8, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021