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Pancreatic AdenocarcinomaPhase 1PANC-001NCT04270929

Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma

A Phase 1 study testing FOLFIRI, FOLFIRINOX and TriSalus Infusion System in people with Pancreatic Adenocarcinoma, run by Roger Williams Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an open label, single institution, dose-escalation phase 1 study designed to assess the feasibility, safety, and efficacy of oxaliplatin administered via Pancreatic Retrograde Venous Infusion (PRVI) using Pressure Enabled Drug Delivery (PEDD) technology. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
FOLFIRI, FOLFIRINOX and TriSalus Infusion System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
23 Dec 2019to 4 May 2021
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with histologically confirmed diagnosis of adenocarcinoma of the pancreas. Patient must have either histologic confirmation of the primary tumor or metastasis.
  • Patients must have locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
  • Patient must be between 18 - 80 years of age.
  • Patient able to understand and sign informed consent.
  • Patient may be chemotherapy naïve or may have failed one line of conventional therapy
  • Prior FOLFIRINOX therapy:
Show all 23Show fewer
  • Patients who have previously received FOLFIRINOX chemotherapy for locally advanced unresectable pancreatic cancer are eligible for enrollment upon this study if they meet the following criteria-
  • FOLFIRINOX chemotherapy was completed more than six months ago,
  • Patients who are currently candidates for re-challenge with FOLFIRINOX chemotherapy for their recurrent cancer, and
  • Patients have no persistent non-hematologic toxicity greater than grade 1 (due to prior FOLFIRINOX therapy)
  • Patients with metastatic cancer who are currently receiving FOLFIRINOX chemotherapy are eligible for enrollment upon this study if they meet the following criteria-
  • Patients have received no more than six cycles of FOLFIRINOX chemotherapy,
  • Patients have at least stable disease on imaging, and
  • Patients have no persistent non-hematologic toxicity greater than grade 1 (due to ongoing FOLFIRINOX therapy)
  • Patient with a life expectancy of greater than six months.
  • Patient with performance status of 0 to 1 (ECOG).
  • All patients must have adequate organ function as defined by:
  • ANC greater than or equal to 1500/mm3, platelets ≥ 100,000/mm3, Hgb ≥ to 8 g/dL; patient may be transfused to achieve Hgb ≥ 8 g/dL to satisfy enrollment criteria, or as otherwise indicated by symptoms for Hgb > 8 g/dL.
  • Creatinine ≤ 1.5mg/dl or creatinine clearance ≤ 60cc/min.
  • Direct bilirubin <1.5X ULN, alkaline phosphatase <5X ULN, and ALT/AST <5X ULN (ULN = upper limit of normal).
  • No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, including uncontrolled atrial fibrillation/atrial flutter, evidence of prior myocardial infarction by history or EKG.
  • No serious, symptomatic obstructive or emphysematous lung disease, or asthma requiring intravenous medications within the past 12 months; no serious lung disease associated with dyspnea at normal activity levels (grade III) or at rest (grade IV), due to any cause (including cancer metastases and pleural effusions).
  • Acceptable vascular anatomy as determined by CT, MR, or conventional venography.

Who cannot join

  • Female patients of childbearing age will be tested for pregnancy. Pregnant and breastfeeding patients will be excluded from the study. Males who are actively seeking to have children will be made aware of the unknown risks of this study protocol on human sperm and the need to practice birth control.
  • Patients with serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic, or allergic disease based on history, physical exam and laboratory tests will be excluded.
  • Patients with uncontrolled diabetes mellitus or a history of pancreatitis.
  • Patients with cholelithiasis and a history of choledocholithiasis.
  • Patients with concurrent malignancies, except for cutaneous carcinomas.
  • Patients with unsuitable vascular anatomy.
  • Portal vein occlusion/thrombosis, history of portal hypertension, cirrhosis, hepatitis, or with radiographic evidence of cirrhosis.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908

Other trials in United States

About this study

This is an open label, single institution, dose-escalation phase 1 study designed to assess the feasibility, safety, and efficacy of oxaliplatin administered via Pancreatic Retrograde Venous Infusion (PRVI) using Pressure Enabled Drug Delivery (PEDD) technology. Oxaliplatin PEDD-PRVI is administered with systemic FOLFIRI followed by FOLFIRINOX therapy for the treatment of patients with unresectable or metastatic pancreatic adenocarcinoma.

Read the detailed description

The treatment period consists of 6 cycles. Cycles 1 and 2 involve the regional administration of oxaliplatin via PEDD-PRVI with systemic FOLFIRI. During cycles 1 and 2, patients are evaluated on days 1, 2, 4, and 8. Cycles 3 through 6 include the systemic administration of standard of care FOLFIRINOX. During cycles 3 through 6, patients are evaluated on days 1 and 8.

Being tested
FOLFIRI, FOLFIRINOX, TriSalus Infusion System
Keywords
Unresectable Pancreatic Cancer, Metastatic Pancreatic Cancer, Oxaliplatin, Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFIRIDrug

    During Cycles 1 and 2, standard of care systemic FOLFIRI will be delivered on Days 2-4 following oxaliplatin PEDD-PRVI.

  • FOLFIRINOXDrug

    During Cycles 3-6, standard of care systemic FOLFIRINOX will be administered on Days 1-3.

  • TriSalus Infusion SystemDevice

    The TriSalus Infusion System administers therapeutics using PEDD technology.

Study groups in NCT04270929
Study groupRoleWhat they receive
Oxaliplatin PEDD-PRVIExperimentalTwo infusions of oxaliplatin (dose escalation: 20-40 mg) over the course of 4 weeks by Pancreatic Retrograde Venous Infusion (PRVI) utilizing Pressure Enabled Drug Delivery (PEDD) technology.
Receives: Drug: FOLFIRI; Drug: FOLFIRINOX; Device: TriSalus Infusion System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Completion Rate of oxaliplatin PEDD-PRVI

    To determine the completion rate of oxaliplatin delivery by PEDD-PRVI as measured by the percentage of successful placements of the TriSalus Infusion System and delivery of the assigned dose of oxaliplatin regionally into the pancreas via RVI per each patient, at each dose-level, and across all enrolled patients in the study. Successful delivery of oxaliplatin by PEDD-PRVI will be confirmed using real-time fluoroscopic guidance. The success rate of completion of PEDD-RVI per patient and acroos all-patients will be calculated

    Measured: 3 months

  2. Safety of oxaliplatin PEDD-PRVI: maximum tolerable dose (MTD)

    To determine the safety of oxaliplatin PEDD-PRVI by identifying the maximum tolerable dose (MTD).

    Measured: 3 months

Secondary outcomes (6)

  1. To determine local progression free survival

    Assess the time frame of pancreatic tumor stability prior to progression by radiographic imaging

    Measured: 3 months

  2. To determine systemic progression free survival.

    Assess the time frame of metastatic tumor stability prior to progression by radiographic imaging

    Measured: 3 months

  3. To determine overall survival

    As a measure of activity, overall survival will be assessed. The events for the assessment of overall survival are death events.

    Measured: 3 months

  4. Radiographic response rates by PET

    Changes in tumor metabolic activity

    Measured: 3 months

  5. Radiographic response rate by perfusion MRI

    Changes in tumor size

    Measured: 3 months

  6. Serologic response rates (CA 19-9)

    Serial measurement of serum CA 19-9 levels

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start23 Dec 2019
  3. Primary completion4 May 2021
  4. Study completion4 May 2021

Why it stopped: Insufficient accrual rate

Resources

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
Model description
This is an open label, single institution, single-arm, dose-escalation phase 1 study, designed to assess the feasibility, safety, and efficacy of oxaliplatin PEDD-PRVI with systemic FOLFIRI followed by FOLFIRINOX therapy for the treatment of patients with unresectable or metastatic pancreatic adenocarcinoma
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04270929
Sponsor's protocol ID
342-30
Acronym
PANC-001
Status last verified
May 2021
First submitted
16 Jan 2020
Last updated
1 Jun 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FOLFIRI, FOLFIRINOX and TriSalus Infusion System in people with Pancreatic Adenocarcinoma, run by Roger Williams Medical Center 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 23 inclusion and 7 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 1 Jun 2021. 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 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?

Completion Rate of oxaliplatin PEDD-PRVI (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04270929.

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 1 Jun 2021.

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