Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX

NCT06353581 | Active Not Recruiting Phase 2

• 1 other identifier: 4-2021-0924
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Neutropenia, a decrease in the number of neutrophils, a type of white blood cell, due to the myelosuppressive effects of chemotherapeutic drugs, is a frequent occurrence in patients receiving anticancer drug therapy, which increases the risk of infection, which can have serious consequences such as antibiotic treatment, hospitalization, intensive care unit treatment, and death, and also reduces the effectiveness of anticancer treatment due to dose reduction and cycle delay. Therefore,G-CSF,which acts as a neutrophil growth factor, can be administered immediately after chemotherapy to increase the production rate of neutrophils and promote the efflux of mature neutrophils from the bone marrow, thereby increasing the absolute neutrophil count. Guidelines for the use of G-CSF published by the NCCN indicate that primary prophylaxis with G-CSF has clinical benefit for patients receiving anticancer drug therapy with a risk of febrile neutropenia greater than 20%. For those at 10-20% risk, consider primary prophylaxis based on risk factors. The frequency of neutropenic fever with FOLFIRINOX chemotherapy, which is commonly used in patients with locally advanced or metastatic pancreatic cancer, was 5.4% in a prospective study of patients receiving high-dose regimens, but 42.5% of patients received prophylactic G-CSF, and 63.0% of patients received prophylactic G-CSF compared to 3.0% when given as postoperative adjuvant therapy demonstrating the need for G-CSF administration.In a retrospective study in Japan, a modified FOLFIRINOX chemotherapy regimen without pegylated G-CSF was associated with a 23% incidence of neutropenic fever and 61.5% grade 3-4 neutropenia, while prophylactic administration of pegylated G-CSF was associated with zero neutropenic fever and grade 3-4 neutropenia and longer survival .A retrospective study from Korea also reported that prophylactic G-CSF administration reduced neutropenic fever from 18.5% to 1.8% and Grade 3-4 neutropenia from 55.6% to 31.6 in pancreatic cancer patients receiving FOLFIRINOX .Pegteograstim (Neulapeg®) is a pegylated human recombinant granulocyte colony-stimulating factor with a long half-life (15-80 hours) compared to filgrastim (3-4 hours). Although several studies have demonstrated that G-CSF primary prophylaxis reduces the frequency of hematologic toxicities, particularly febrile neutropenia, during chemotherapy, it has not been prospectively studied whether primary prophylaxis reduces the frequency of grade 3-4 neutropenia and neutropenic fever in the modified FOLFIRINOX chemotherapy regimen in patients with pancreatic cancer. Therefore, this study is designed to determine if prophylactic administration of NEURAPEC reduces the frequency of Grade 3-4 neutropenia and neutropenic fever in patients with locally advanced or metastatic pancreatic cancer receiving modified FOLFIRINOX chemotherapy.

Conditions

Locally Advanced Pancreatic Cancer; Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Development of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL)

  The occurrence of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC\<1000/mL) and the occurrence of neutropenic fever (febrile neutropenia) will be tested using the chi-squared test.

  4 years

• development of neutropenic fever (febrile neutropenia)

  The occurrence of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC\<1000/mL) and the occurrence of neutropenic fever (febrile neutropenia) will be tested using the chi-squared test.

  4 years

Secondary Outcomes (8)

• relative dose intensity

  4 years

• quality of life assessed according to EORTC QLQ-C30

  4 years

• Number of patients experiencing Adverse events (AEs)

  4 years

• objective response rate

  4 years

• Progression-free survival

  4 years

Study Arms (2)

Neulapeg

EXPERIMENTAL

Neulapeg

Drug: Neulapeg; Other: Control

Control

NO INTERVENTION

If grade 3-4 neutropenia or neutropenic fever occurs, patients will be crossover to Neulapeg.

Interventions

Neulapeg DRUG

Participants will receive Neulapeg subcutaneously 24 hours after the end of modified FOLFIRINOX dosing. (Must be administered within a maximum of 72 hours; Neulapeg will only be given for up to 8 cycles).

Neulapeg

Control OTHER

Patients assigned to the non-Neulapeg arm will be crossover to Neulapeg if they develop grade 3-4 neutropenia or neutropenic fever. Crossover subjects will receive up to 8 cycles of Neulapeg as a secondary treatment regardless of starting cycle.

Neulapeg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pancreatic cancer assessed as locally advanced or metastatic by histology/cytology or imaging studies including CT or MRI
• Patients who are scheduled to receive modified FOLFIRINOX chemotherapy (less than second-line treatment as a consolidation regimen)
• Patients with an ECOG performance capacity index of 0 to 1
• Patients 19 years of age or older who are willing and able to complete a written informed consent for this study
• Patients with adequate organ function
• Patients who voluntarily agree to participate in the study

You may not qualify if:

• Other histologic/cytologic or imaging diagnosis other than pancreatic ductal adenocarcinoma (e.g., neuroendocrine tumor, etc.)
• Patients with moderate acute or chronic medical conditions or abnormal laboratory findings that would affect the results of this study.
• Pregnant or lactating women or patients planning to become a mother during the scheduled study period from the screening visit through Day 120 after the last dose of study drug
• Active systemic infection that is not resolving

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

• Lee CK, Kim I, Seo DH, Park S, Kim M, Lee SH, Lee YJ, Kim JH, Kim CG, Choi HJ. Pegylated granulocyte colony-stimulating factor primary prophylaxis versus no prophylaxis in patients with unresectable pancreatic cancer treated with modified-FOLFIRINOX: a randomized, open-label, multicenter, phase 2 trial. EClinicalMedicine. 2025 Nov 14;90:103646. doi: 10.1016/j.eclinm.2025.103646. eCollection 2025 Dec.

  PMID: 41324016 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 9, 2024
• Study Start: February 16, 2022
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)