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Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors

ConditionSmall Bowel Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTiago Biachi de Castria

About this trial

The study regimen will be administered on an outpatient basis and all medications are administered intravenously (IV). Subjects will receive treatment on Day 1 and Day 15 of each 28-day cycle consisting of the following: nanoliposomal irinotecan at 50 mg/m2, followed by oxaliplatin 60 mg/m2, followed by leucovorin at 400 mg/m2 30 minutes after completion of oxaliplatin, followed by 5-FU 2400 mg/m2 60 minutes after leucovorin completion. Subjects will receive up to 6 cycles of NALIRIFOX then based on response and per physician discretion, de-escalated maintenance treatment with NALIRIFOX minus oxaliplatin may continue. Subjects will continue de-escalated maintenance treatment until progression per RECIST 1.1, intolerable toxicity or physician/subject choice to discontinue.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject has been informed about the nature of the study, and has agreed to participate in the study, and signed the ICF prior to participation in any study-related activities. Also, as determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Age ≥ 18 years at the time of consent.

ECOG Performance Status of ≤ 1 within 28 days prior to registration.

Histological or cytologically confirmed small bowel adenocarcinoma per AJCC staging manual, 8th edition that has not been previously treated in the metastatic setting. Subjects with only localized disease or disease which will likely become resectable after chemotherapy (per investigator discretion) are NOT eligible. NOTE: Subjects may have received one cycle of FOLFOX without biologic therapy prior to screening for this trial.

Disqualifiers

Adenocarcinoma originating in the ampulla or appendix. NOTE: Duodenal tumors that involve the ampulla but originate in the duodenum are eligible. In addition, ampullary cancers that demonstrate an intestinal phenotype based on H&E and/or IHC (excluding biliary phenotype) are eligible.

Neuroendocrine or any other histology different than adenocarcinoma.

Prior treatment with irinotecan.

Palliative radiotherapy is permitted but lesions in a prior radiation field must have progressed subsequent to radiotherapy to be considered measurable.

Trial design

Design model

Single group

Treatments tested in this trial

  • Nanoliposomal irinotecan

    Drug

    Nanoliposomal Irinotecan 50 mg/m2 will be administered over 90 minutes (± 10 minutes) IV. All subjects must be pre-medicated prior to nanoliposomal irinotecan infusion with standard doses of dexamethasone and a 5-HT3 antagonist, or equivalent other anti-emetics (according to standard institutional practices).

  • Oxaliplatin

    Drug

    Oxaliplatin 60 mg/m2 will be administered over 120 minutes (± 10 minutes) IV. Institutional standards may be used for all aspects of oxaliplatin administration including premedication administration.

  • 5 fluorouracil

    Drug

    5-FU will be administered as a continuous infusion over 46 hours. Subjects will go home with an infusion pump and return to clinic at the end of infusion for removal of the pump or, if possible, the pump may be removed at the subject's home (except on Cycle 1 Day 3).

  • Leucovorin

    Drug

    Leucovorin 400 mg/m2 will be administered over 30 minutes IV.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: NALIRIFOX and De-escalated maintenanceExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

ORR is defined as the proportion of subjects with a confirmed complete or partial response to treatment according to RECIST 1.1, by local assessment.

Time frame
3 years

Secondary outcomes

1

Overall Survival (OS)

OS is defined as the time from initiation of study regimen to date of death due to any cause.

Time frame
3 years
2

Time to Progression (TTP)

TTP is defined as the time from initiation of study regimen to date of disease progression by RECIST 1.1.

Time frame
3 years
3

Duration of Response (DOR)

DOR is defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD (per RECIST 1.1) or ro death due to any cause, whichever comes first.

Time frame
3 years
4

Number of Participants with Adverse Events

Adverse events will be assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.

Time frame
3 years

Other outcomes

Sponsors and contacts

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

Tiago Biachi de Castria

Lead sponsor

Hoosier Cancer Research Network

Sponsor institution

Ipsen

Collaborator

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Source ClinicalTrials.gov
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