Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Phase 1RecruitingNCT03484299

University of Louisville20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreas Cancer

Interventions

Irreversible Electroporation (IRE)PROCEDURE

Non-thermal ablation of tumor

GemcitabineDRUG

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

FOLFIRINOXDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Louisville

Louisville, Kentucky, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)

Adverse and Serious Adverse events will be collected and analyzed

Time frame: Time from first dose until subject has reached 90 days post last active study treatment

Secondary Outcomes

Progression free survival

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.

Time frame: Time from first dose date to first date of confirmed disease progression, assessed for 90 days

Central Contacts

Robert Martin, MD, PhD

CONTACT

502-629-3355 robert.martin@louisville.edu

Data from ClinicalTrials.gov

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