Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma:

NCT03861702 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: BTCRC-GI15-067
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

Brief Summary

This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX-nal-IRI) for treatment of patients with locally advanced pancreatic carcinoma (LAPC).

Conditions

Locally Advanced Pancreatic Carcinoma(LAPC)

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Disease Control Rate (DCR) = CR +PR+SD

  Up to 22 months

Secondary Outcomes (12)

• Objective Response Rate (ORR) at 8 Weeks

  8 weeks

• Objective Response Rate (ORR) at 16 Weeks

  16 weeks

• Objective Response Rate (ORR) at 24 Weeks

  24 weeks

• Stable Disease Rate (SDR) at 8 Weeks

  8 Weeks

• Stable Disease Rate (SDR) at 16 Weeks

  16 Weeks

Study Arms (1)

FOLFOX + Irinotecan

EXPERIMENTAL

Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle.

Drug: FOLFOX regimen; Drug: Liposomal Irinotecan

Interventions

FOLFOX regimen DRUG

FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil)

FOLFOX + Irinotecan

Liposomal Irinotecan DRUG

Liposomal Irinotecan

Also known as: nal-Irinotecan

FOLFOX + Irinotecan

Eligibility Criteria

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

You may qualify if:

• Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 18 years at the time of consent.
• ECOG Performance Status of 0-1 within 28 days prior to registration.
• Histological or cytological confirmation of pancreatic carcinoma.
• Measurable disease according to RECIST v1.1 within 28 days prior to registration.
• Previously untreated pancreatic carcinoma considered as locally advanced unresectable according to NCCN guidelines.
• Demonstrate adequate organ function as defined in the table below; All screening labs to be obtained within 14 days prior to initiation of study treatment.
• Hematological
• Absolute Neutrophil Count (ANC): \>/=1500/uL
• Hemoglobin (Hgb): \>/=8 g/dL with blood transfusion permitted
• Platelet (Plt): \>/=100,000/uL
• Renal
• Serum creatinine: \</=1.5 x upper limit of normal (ULN) OR
• Calculated creatinine clearance using the Cockcroft-Gualt formula: \>/=50 mL/min for subjects with creatinine levels \>1.5 ULN
• Hepatic

You may not qualify if:

• Known hypersensitivity to irinotecan liposome, other liposomal products, oxaliplatin, 5-fluorouracil, leucovorin, or any ingredients in those preparations.
• Pre-existing peripheral neuropathy (Grade 3 or 4) during screening.
• Major surgery within 4 weeks of starting treatment.
• Active uncontrolled cardiac arrhythmia or congestive heart failure (class 3 or 4 as defined by the New York Heart Association Functional Classification); or history of myocardial infarction, unstable angina; or acute coronary syndrome within 6 months prior to enrollment.
• Known history of human immunodeficiency virus (HIV), or hepatic cirrhosis caused by active infection with hepatitis B virus (HBV, as defined by HBsAg positivity or positive DNA). Testing is not required for study entry if there is no clinical suspicion. Note: hepatic cirrhosis caused by other factors (ex. alcoholic cirrhosis) may be considered on a case-by-case basis if, in the opinion of the treating investigator, the disease is unlikely to compromise the subject's safety or put the study outcomes at unnecessary risk.
• Any medical condition, life-threatening illness, or organ dysfunction, which in the investigator's opinion, can compromise the subject's safety or put the study outcomes at unnecessary risk.
• Uncontrolled active systemic infection.
• Concomitant medications that are prohibited in this study and they cannot be switched to alternative medications.
• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
• Known additional malignancy that is active and/or progressive requiring treatment within 2 years of screening for this study; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, low-grade prostate cancer, or other cancer for which the subject has been disease-free for at least five years. Additional exceptions could be considered if agreed by sponsor-investigator and site investigator assuming the disease is considered extremely unlikely to confound evaluation of disease status.
• Treatment with any investigational drug within 30 days prior to registration, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing of this study.

Sponsors & Collaborators

• Nelson Yee: lead
• Ipsen: collaborator

Study Sites (4)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Rutgers Cancer Institute of new Jersey

New Brunswick, New Jersey, 08903, United States

Location

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Interventions

Folfox protocol; irinotecan sucrosofate

Results Point of Contact

• Title: Fauzia Sharmin
• Organization: Hoosier Cancer Research Network

fsharmin@hoosiercancer.org

317-921-2050

Study Officials

• Nelson Yee

  Penn State Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: This is a phase II, single-arm, open-label, clinical study.

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 4, 2019
• Study Start: September 2, 2020
• Primary Completion: August 16, 2023
• Study Completion: September 27, 2024
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)