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NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial

ConditionBorderline Resectable Pancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

About this trial

This phase II trial tests how well liposomal irinotecan, oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) before surgery works in treating patients with pancreatic ductal adenocarcinoma that is close to major blood vessels, but is still potentially removable by surgery (borderline resectable). Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Liposomal irinotecan is a form of the anticancer drug irinotecan that is contained inside very tiny, fat-like particles. Liposomal irinotecan may have fewer side effects and work better than other forms of the drug. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. 5-fluorouracil, a type of antimetabolite, stops cells from making DNA and it may kill tumor cells. Leucovorin, a form of folic acid, is used to lessen the toxic effects of substances that block the action of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Giving NALIRIFOX before surgery may improve the chance of successful surgery and decrease the chance of the cancer returning after surgery in patients with borderline resectable pancreatic ductal adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 old

Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) that is borderline resectable (BR) using the National Comprehensive Cancer Network criteria

Have a documented Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Absolute neutrophil count (ANC) ≥ 1,500 cells/uL without the use of hematopoietic growth factors

Disqualifiers

Patients who have had previous chemotherapy or radiotherapy for PDAC

Patients with resectable, unresectable, or metastatic PDAC

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Pregnant or nursing female participants

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Fluorouracil

    Drug

    Given IV

  • Irinotecan Sucrosofate

    Drug

    Given IV

  • Leucovorin Calcium

    Drug

    Given IV

  • Oxaliplatin

    Drug

    Given IV

  • Surgical Procedure

    Procedure/Surgery

    Undergo surgical resection

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment (NALIRIFOX)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Major pathologic response (MPR)

MPR will be defined as either complete pathologic response or minimal residual cancer based on the American College of Pathology system. The MPR status will be summarized using frequencies and relative frequencies.

Time frame
Up to 5 years

Secondary outcomes

1

Objective response rate (ORR)

Will be assessed using Response Evaluation Criteria in Solid Tumors 1.1. ORR will be summarized using frequencies and relative frequencies. Estimates of rates will be obtained with 90% credible regions obtained by Jeffrey's prior method.

Time frame
Up to 5 years
2

CA19-9 response rate

Will be summarized using frequencies and relative frequencies. Estimates of rates will be obtained with 90% credible regions obtained by Jeffrey's prior method.

Time frame
Up to 5 years
3

Carcinoembryonic antigen response rate

Will be summarized using frequencies and relative frequencies. Estimates of rates will be obtained with 90% credible regions obtained by Jeffrey's prior method

Time frame
Up to 5 years
4

Positive margin resection rate

Will be summarized using frequencies and relative frequencies. Estimates of rates will be obtained with 90% credible regions obtained by Jeffrey's prior method

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roswell Park Cancer Institute

Lead sponsor

Source ClinicalTrials.gov
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