A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

NCT03483038 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: UF-STO-PANC-004IRB201800866 -AOCR16281
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

Brief Summary

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Conditions

Pancreatic Adenocarcinoma

Keywords

pancreatic adenocarcinoma; neoadjuvant; ONIVYDE; chemotherapy; borderline resectable; resectable

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Who Had Post-operative Complications 30 Days Post-surgery

  To determine the percentage of subjects who had post-operative complications 30 days post-surgery. Post-operative complications considered for this outcome measure included hospital readmission, death, second surgery or interventional procedure, or major complications extending hospital stay.

  30 days

Secondary Outcomes (5)

• Percentage of Subjects Who Completed All Intended Cycles of Treatment

  4 months

• Percentage of Subjects Who Achieved a Complete Surgical Resection (R0)

  7 months

• Percentage of Patients Achieving a Best Overall Response of Partial or Complete Response (Objective Response Rate)

  5 months

• Difference Between Baseline and Maximal Nadir of Serum CA19-9 Level

  9 months

• Subject Physical, Social, Emotional, and Functional Well-being During Treatment

  Cycles 1, 5, and 8 and at pre-surgical evaluation and post-surgical follow-up visits

Study Arms (1)

Liposomal irinotecan with FOLFOX

EXPERIMENTAL

Subjects will receive 8 cycles and each cycle is 14 days.

Drug: Liposomal Irinotecan; Drug: FOLFOX regimen

Interventions

Liposomal Irinotecan DRUG

Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle.

Also known as: ONIVYDE

Liposomal irinotecan with FOLFOX

FOLFOX regimen DRUG

Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.

Liposomal irinotecan with FOLFOX

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age.
• A new clinical diagnosis of resectable or borderline resectable, previously untreated pancreatic adenocarcinoma confirmed by pathologic specimen evaluation
• No clinical evidence of metastatic disease
• Potentially resectable local disease, as confirmed by CT or MRI of the abdomen
• ECOG performance status of 0 or 1
• Any biliary obstruction must have been treated.
• Subjects with known or suspected Gilbert's disease must be formally tested for UGT1A1\*28 with results available to study team prior to treatment initiation
• Adequate organ function; as defined by:
• i. Hematologic-
• ANC \> 1,500 cells/μl without the use of hematopoietic growth factors; and
• Platelet count \> 100,000 cells/μl; and
• Hemoglobin \> 9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL)
• ii. Hepatic-
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• Serum total bilirubin within 1.5 x upper limit of normal (ULN) for the institution, with a trend downwards (biliary drainage is allowed for biliary obstruction),

You may not qualify if:

• A medical history of prior anti-cancer treatment for pancreatic cancer.
• Locally advanced unresectable disease or evidence of metastatic disease.
• Any other invasive malignancy within the past three years.
• Presence of any known contraindications to or hypersensitivities to the investigational products.
• Use of strong CYP3A4 inhibitors or inducers which cannot be discontinued prior to study entry.
• A non-surgical candidate.
• Subject is unable to understand, provide consent or comply with study requirements, treatments or instructions in the opinion of the treating physician.
• Uncontrolled diarrhea, active infection, known interstitial lung disease or other medical condition that precludes safe administration of this combination therapy consistent with manufacturer recommendations.
• Unwilling/unable to comply with birth control requirements while on study.
• Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 7 months for females and 4 months for males after the last dose of study drug.
• Females who are pregnant or breastfeeding.
• History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
• Prisoners or subjects who are involuntarily incarcerated.
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
• Subjects demonstrating an inability to comply with the study and/or follow-up procedures.

Sponsors & Collaborators

• University of Florida: lead
• Ipsen: collaborator

Study Sites (4)

University of Florida

Gainesville, Florida, 32608, United States

Location

Orlando Health UF Health Cancer Center

Orlando, Florida, 32806, United States

Location

Tallahassee Memorial Health Care

Tallahassee, Florida, 32308, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Singhal R, Rogers SC, Lee JH, Ramnaraign B, Sahin I, Fabregas JC, Thomas RM, Hughes SJ, Nassour I, Hitchcock K, Russell K, Kayaleh O, Turk A, Zlotecki R, DeRemer DL, George TJ. A phase II study of neoadjuvant liposomal irinotecan with 5-FU and oxaliplatin (NALIRIFOX) in pancreatic adenocarcinoma. Future Oncol. 2023 Sep;19(27):1841-1851. doi: 10.2217/fon-2023-0256. Epub 2023 Sep 27.

  PMID: 37753702 DERIVED

MeSH Terms

Interventions

irinotecan sucrosofate; Folfox protocol

Results Point of Contact

• Title: Allison Allegra
• Organization: University of Florida

allisonallegra3@ufl.edu

352-294-5691

Study Officials

• Thomas George, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 29, 2018
• Study Start: December 13, 2018
• Primary Completion: September 16, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026
• Results First Posted: September 23, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)