Pancreatic AdenocarcinomaPhase 1NCT02514421
Evaluation of Safety and Efficacy of Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma
A Phase 1 study testing Electroporation, gemcitabine and nab-paclitaxel in people with Pancreatic Adenocarcinoma, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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?
- Electroporation, gemcitabine and nab-paclitaxel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 18 Apr 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 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;
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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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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 gemcitabine and nab-paclitaxel. The schedule of administration of gemcitabine and nab-paclitaxel 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
- Electroporation, gemcitabine, nab-paclitaxel
- 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.
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.
gemcitabineDrug
Also called Gemzar
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.
nab-paclitaxelDrug
Also called Abraxane
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electroporation; Drug: gemcitabine; Drug: nab-paclitaxel |
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 (7)
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 and associated imaging characteristics after electrochemotherapy
Gene expression characteristics are identified by biopsy specimen evaluation. Imaging characteristics are evaluated by MRI and MRS.
Measured: 1 year
Number of groups of patients who have similar pancreatic tumor gene expression characteristics and associated clinical outcomes after electrochemotherapy
Gene expression characteristics are identified by biopsy specimen evaluation. 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 posted3 Aug 2015 (estimated)
- Study startJul 2015
- Primary completion18 Apr 2017
- Study completion18 Apr 2017
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
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil K Pillai, The University of Texas Health Science Center, Houston
- Investigators
- Anil K Pillai, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514421
- Sponsor's protocol ID
- HSC-MS-14-0701
- Status last verified
- Apr 2019
- First submitted
- 30 Jul 2015
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02514421
- Acronym / sponsor ID
- HSC-MS-14-0701
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- pancreatic adenocarcinoma, electrochemotherapy, electroporation, radiogenomics, imaging, magnetic resonance spectroscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 18 Apr 2017 (actual)
- First posted
- 3 Aug 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 gemcitabine and nab-paclitaxel. The schedule of administration of gemcitabine and nab-paclitaxel 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 gemcitabine/nab-paclitaxel | Experimental | Device: Electroporation, Drug: gemcitabine, Drug: nab-paclitaxelDuring 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. |
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 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;
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 |
|---|---|---|
| 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 gemcitabine/nab-paclitaxel |
| gemcitabineAlso: GemzarThe 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. | Drug | Electrochemotherapy with gemcitabine/nab-paclitaxel |
| nab-paclitaxelAlso: AbraxaneThe chemotherapy schedule will include administration of nab-paclitaxel 125mg/m2 intravenous (IV) over approximately 30 to 45 minutes on Days 1, 8, and 15. | Drug | Electrochemotherapy with gemcitabine/nab-paclitaxel |
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.
7 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 and associated imaging characteristics after electrochemotherapy
Time frame: 1 year
Number of groups of patients who have similar pancreatic tumor gene expression characteristics and associated clinical outcomes after electrochemotherapy
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
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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.
Anil K Pillai, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Electroporation, gemcitabine and nab-paclitaxel in people with Pancreatic Adenocarcinoma, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 29 Apr 2019.