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
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 treated in the adjuvant setting who completed treatment > 6 months prior to registration and do not have residual toxicities > Grade 1 are eligible. NOTE: Subjects with only localized disease or disease which will likely become resectable after chemotherapy (per investigator discretion) are NOT eligible.
Disqualifiers
Adenocarcinoma originating in the ampulla or appendix (duodenal tumors that involve the ampulla but originate in the duodenum 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
Treatments tested in this trial
- Nanoliposomal irinotecan
- Oxaliplatin
- 5 fluorouracil
- Leucovorin
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
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