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Study of FOLFIRINOX Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma

NCT02592395 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-10-17

No results posted yet for this study

Summary

The purpose of this study is to see how well electrochemotherapy works at treating people with Stage III pancreatic adenocarcinoma. Electrochemotherapy is a treatment that combines electroporation and chemotherapy administration. Electroporation uses an electric current to produce holes in pancreatic tumor, which causes the tumor cells to die or take up a higher concentration of administered chemotherapy agent. This study will test the safety and look at the effect of electrochemotherapy in the treatment of stage III pancreatic adenocarcinoma. This study will also help to find the safest and most effective amount of electroporation voltage to apply to this type of tumor.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

FOLFIRINOX

The chemotherapy schedule will include administration of FOLFIRINOX (5-Fluorouracil, Irinotecan, Oxaliplatin, and Leucovorin) will be: Day 1: Oxaliplatin at 85mg/m2 over 120 minutes, Irinotecan 180mg/m2 over 90 minutes, Leucovorin 400mg/m2 over 90minutes, 5-Fluorouracil (5-FU) 1200mg/m2/day continuous infusion (CIV) over 46 hours. Day 3: 5-FU CIV pump will be disconnected. Neulasta injection 6mg subcutaneous

DEVICE

Electroporation

Irreversible electroporation (IRE) will be performed under computed tomography (CT) guidance, during which 2 to 6 needles are advanced into the pancreatic tumor where a specified field strength will be applied.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Derek L West, MD, MS · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-10-31
Completion
2017-10-31
FDA Drug
Yes
FDA Device
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02592395 on ClinicalTrials.gov