Pancreatic AdenocarcinomaPhase 1NCT02592395
Study of FOLFIRINOX Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma
A Phase 1 study testing FOLFIRINOX and Electroporation in people with Pancreatic Adenocarcinoma, run by The University of Texas Health Science Center, Houston.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- FOLFIRINOX and Electroporation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- Prior chemotherapy with FOLFIRINOX;
- 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;
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- 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
About this study
Official title: Phase I Study of FOLFIRINOX Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma
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.
Read the detailed description
This is a phase I dose escalation trial using a 3 + 3 dose escalation scheme to evaluate the maximum tolerated field strength dose of administered irreversible electroporation in combination with chemotherapy. During the first cycle of chemotherapy, patients will receive electroporation of the primary pancreatic tumor prior to administration of chemotherapy with FOLFIRINOX. The schedule of administration of FOLFIRINOX will be administered as per standard of care. The investigators will use non-invasive dynamic magnetic resonance imaging and magnetic resonance spectroscopy to detect and describe changes within the tumor. Safety will be determined by assessing the number of class three or higher toxicity events in cohorts of 6 patients at progressively higher electroporation voltages. The maximum tolerated dose (MTD) will be defined as one voltage level less than the voltage at which two or more patients out of six total patients have a class three or higher toxicity event.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- FOLFIRINOX, Electroporation
- Keywords
- pancreatic adenocarcinoma, electrochemotherapy, electroporation, radiogenomics, imaging, magnetic resonance spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRINOXDrug
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
ElectroporationDevice
Also called Irreversible electroporation (IRE)
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrochemotherapy with FOLFIRINOX | Experimental | During the first cycle of chemotherapy, patients will receive electroporation of the primary pancreatic tumor prior to administration of chemotherapy with FOLFIRINOX . The schedule of administration of FOLFIRINOX will be administered as per standard of care. Receives: Drug: FOLFIRINOX; Device: Electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (8)
Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by time to progression
Time to progression is the time after treatment until tumor enlargement or metastatic disease is identified.
Measured: 1 year
Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by one year survival
One year survival is the number of patients who are alive one year after treatment.
Measured: 1 year
Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by tumor imaging
We will assess tumor size changes and tumor staging through magnetic resonance imaging (MRI).
Measured: 1 year
Number of participants who demonstrated diffusion weighted magnetic resonance imaging (MRI) changes
Measured: 1 year
Number of participants who demonstrated magnetic resonance spectroscopy (MRS) changes
Measured: 1 year
Number of groups of patients who have similar pancreatic tumor gene expression characteristics after electrochemotherapy
Gene expression characteristics are identified by biopsy specimen evaluation.
Measured: 1 year
Number of groups of patients who have similar imaging characteristics after electrochemotherapy
Imaging characteristics are evaluated by MRI and MRS.
Measured: 1 year
Number of groups of patients who have similar clinical outcomes after electrochemotherapy
Clinical outcomes are evaluated by time to progression and 1 year survival. Time to progression is the time after treatment until tumor enlargement or metastatic disease is identified. One year survival is the number of patients who are alive one year after treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: PI transferred to another institution and did not take this study with him.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Derek L West, MD, MS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592395
- Sponsor's protocol ID
- HSC-MS-15-0659
- Status last verified
- Oct 2018
- First submitted
- 28 Oct 2015
- Last updated
- 17 Oct 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of FOLFIRINOX Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02592395
- Acronym / sponsor ID
- HSC-MS-15-0659
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- pancreatic adenocarcinoma, electrochemotherapy, electroporation, radiogenomics, imaging, magnetic resonance spectroscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI transferred to another institution and did not take this study with him.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Oct 2015 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase I dose escalation trial using a 3 + 3 dose escalation scheme to evaluate the maximum tolerated field strength dose of administered irreversible electroporation in combination with chemotherapy. During the first cycle of chemotherapy, patients will receive electroporation of the primary pancreatic tumor prior to administration of chemotherapy with FOLFIRINOX. The schedule of administration of FOLFIRINOX will be administered as per standard of care. The investigators will use non-invasive dynamic magnetic resonance imaging and magnetic resonance spectroscopy to detect and describe changes within the tumor. Safety will be determined by assessing the number of class three or higher toxicity events in cohorts of 6 patients at progressively higher electroporation voltages. The maximum tolerated dose (MTD) will be defined as one voltage level less than the voltage at which two or more patients out of six total patients have a class three or higher toxicity event.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrochemotherapy with FOLFIRINOX | Experimental | Drug: FOLFIRINOX, Device: ElectroporationDuring the first cycle of chemotherapy, patients will receive electroporation of the primary pancreatic tumor prior to administration of chemotherapy with FOLFIRINOX . The schedule of administration of FOLFIRINOX will be administered as per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (10 listed)
- Prior chemotherapy with FOLFIRINOX;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFIRINOXThe 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 | Drug | Electrochemotherapy with FOLFIRINOX |
| ElectroporationAlso: Irreversible electroporation (IRE)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. | Device | Electrochemotherapy with FOLFIRINOX |
Primary outcome
Number of participants who experienced dose limiting toxicities (DLTs)
Time frame: 4 weeks
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.
8 secondary outcomes
Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by time to progression
Time frame: 1 year
Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by one year survival
Time frame: 1 year
Number of participants who demonstrated no clinical change or clinical improvement in pancreatic adenocarcinoma outcome as assessed by tumor imaging
Time frame: 1 year
Number of participants who demonstrated diffusion weighted magnetic resonance imaging (MRI) changes
Time frame: 1 year
Number of participants who demonstrated magnetic resonance spectroscopy (MRS) changes
Time frame: 1 year
Number of groups of patients who have similar pancreatic tumor gene expression characteristics after electrochemotherapy
Time frame: 1 year
Number of groups of patients who have similar imaging characteristics after electrochemotherapy
Time frame: 1 year
Number of groups of patients who have similar clinical outcomes after electrochemotherapy
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek L West, MD, MS principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FOLFIRINOX and Electroporation in people with Pancreatic Adenocarcinoma, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who experienced dose limiting toxicities (DLTs) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.