Evaluation of Safety and Efficacy of Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma

NCT02514421 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: HSC-MS-14-0701
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pancreatic adenocarcinoma; electrochemotherapy; electroporation; radiogenomics; imaging; magnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (1)

• Number of participants who experienced dose limiting toxicities (DLTs)

  A dose limiting toxicity (DLT) is any Grade 3 or 4 adverse event (AE) using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) that is possibly related to the electrochemotherapy treatment. CTCAE 4.0 Grade 3 is a severe AE and Grade 4 is a life-threatening or disabling AE. DLTs are collected to determine the Maximum Tolerated Dose (MTD), which is defined as as one field strength level less than the field strength at which two or more patients out of six total patients experience a DLT.

  4 weeks

Secondary Outcomes (7)

• Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by time to progression

  1 year

• Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by one year survival

  1 year

• Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by tumor imaging

  1 year

• Number of participants who demonstrated diffusion weighted magnetic resonance imaging (MRI) changes

  1 year

• Number of participants who demonstrated magnetic resonance spectroscopy (MRS) changes

  1 year

Study Arms (1)

Electrochemotherapy with gemcitabine/nab-paclitaxel

EXPERIMENTAL

During the first cycle of chemotherapy, patients will receive electroporation of the primary pancreatic tumor prior to administration of chemotherapy with gemcitabine and abraxane. The schedule of administration of gemcitabine and nab-paclitaxel will be administered as per standard of care. The chemotherapy schedule will include administration of nab-paclitaxel 125mg/m2 intravenous (IV) over approximately 30 to 45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000mg/m2 IV infusion over approximately 30 minutes on days 1, 8, and 15 of each 28 day cycle.

Device: Electroporation; Drug: gemcitabine; Drug: nab-paclitaxel

Interventions

Electroporation DEVICE

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.

Also known as: Irreversible electroporation (IRE)

Electrochemotherapy with gemcitabine/nab-paclitaxel

gemcitabine DRUG

The chemotherapy schedule will include administration of gemcitabine 1000mg/m2 IV infusion over approximately 30 minutes on days 1, 8, and 15 of each 28 day cycle.

Also known as: Gemzar

Electrochemotherapy with gemcitabine/nab-paclitaxel

nab-paclitaxel DRUG

The chemotherapy schedule will include administration of nab-paclitaxel 125mg/m2 intravenous (IV) over approximately 30 to 45 minutes on Days 1, 8, and 15.

Also known as: Abraxane

Electrochemotherapy with gemcitabine/nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven pancreatic carcinoma which is safely accessible by percutaneous methods;
• Locally advanced un-resectable pancreatic adenocarcinoma;
• At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (longest diameter \>=20 mm using conventional techniques or \>=10 mm with spiral CT or MRI scan);
• WHO performance status (PS) \< 2 or Eastern Cooperative Oncology Group \< 2;
• Age \>18;
• Life expectancy \> 3 months;
• No history of gastric or esophageal varices;
• No active, uncontrolled infection;
• All patients must have adequate physiologic (hematologic, renal and hepatic) reserves as evidenced by: neutrophil count \>1500/mL; platelet count \>100,000/mL; serum creatinine \<1.5x the upper limit of normal (ULN) value; serum glutamic-pyruvic transaminase (SGPT) \<2.5 x ULN and bilirubin \<1.5 x ULN functions
• Pain and biliary obstruction controlled before the start of the study
• Absence of psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
• Women of childbearing potential (defined as sexually mature woman who 1) has not undergone hysterectomy \[the surgical removal of the uterus\] or bilateral oophorectomy \[the surgical removal of both ovaries\] or 2) has not been naturally post-menopausal for at last 24 consecutive months) must have a negative pregnancy test prior to starting therapy. Men and women of childbearing potential must be willing to use effective contraceptive while on treatment and for a reasonable period thereafter.

You may not qualify if:

• Prior chemotherapy with gemcitabine and nab-paclitaxel;
• Prior history of pancreatic electroporation;
• Untreatable contrast allergy;
• History of allergy or hypersensitivity to gemcitabine, nab-paclitaxel, or any of the excipients;
• Presence of metal biliary stent;
• Psychosis or seizures;
• Evidence of serious gastrointestinal bleeding or bowel obstruction;
• Pregnant or lactating women;
• Women of childbearing potential who are not using adequate protection;
• Inability to tolerate MRI imaging

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Electroporation; Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Anil K Pillai, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 3, 2015
• Study Start: July 1, 2015
• Primary Completion: April 18, 2017
• Study Completion: April 18, 2017
• Last Updated: April 29, 2019

Record last verified: 2019-04

Locations

US (1)