Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353581
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-13
Brief Title:
Prophylactic Administration of Neulapeg Pegteograstim in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Phase II Open Label Study of the Efficacy and Safety of Neulapeg Pegteograstim in Patients With Locally Advanced or Metastatic Pancreatic Cancer Treated With Modified FOLFIRINOX
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ThereforeG-CSFwhich 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 54 in a prospective study of patients receiving high-dose regimens but 425 of patients received prophylactic G-CSF and 630 of patients received prophylactic G-CSF compared to 30 when given as postoperative adjuvant therapy demonstrating the need for G-CSF administrationIn a retrospective study in Japan a modified FOLFIRINOX chemotherapy regimen without pegylated G-CSF was associated with a 23 incidence of neutropenic fever and 615 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 185 to 18 and Grade 3-4 neutropenia from 556 to 316 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
Detailed Description:
1 Subjects who meet the inclusionexclusion criteria for this study will be randomized to two arms Arm A and Arm B alternating between patients receiving prophylactic Neulapeg and patients not receiving prophylactic Neulapeg Once assigned they will be followed until the end of the 8th cycle of modified FOLFIRINOX
2 Patients assigned to the arm receiving prophylactic Neulapeg will receive Neulapeg subcutaneously 24 hours after the end of modified FOLFIRINOX dosing This should be administered no later than 72 hours and Neulapeg will only be given for a maximum of 8 cycles
3 Patients in both arms will have additional visits at the discretion of the investigator for hematologic toxicity surveillance on days 7-10 of modified FOLFIRINOX dosing during the first 4 cycles Thereafter patients will be seen only at the time of chemotherapy administration at the discretion of the investigator
4 Patients in both arms will be instructed to return for any fever greater than 383 degrees Celsius or greater than 380 degrees Celsius lasting more than 1 hour
5 Patients assigned to the arm not receiving prophylactic Neulapeg will not receive intervention with G-CSF for neutropenia of grade 2 or less
6 Patients assigned to the no prophylactic Neulapeg arm will be crossover to prophylactic Neulapeg if they develop Grade 3-4 neutropenia or neutropenic fever Crossover subjects will receive up to 8 cycles of prophylactic Neulapeg as a secondary treatment regardless of starting cycle
7 Hematologic toxicity monitored every cycle for 8 cycles Quality of life assessed according to EORTC QLQ-C30 at baseline once every 2 weeks for a total of 5 times Baseline Cycle 2 Day 1 Cycle 4 Day1 Cycle 6 Day 1 Cycle 8 Day 1 completion of the bone pain questionnaire at baseline once every 1 cycle for the first 4 cycles and then every 2 cycles for a total of 7 times Baseline Cycle 1 Day 1 Cycle 2 Day 1 Cycle 3 Day 1 Cycle 4 Day 1 Cycle 6 Day 1 Cycle 8 Day 1 The mFOLFIRINOX will be administered every 2 weeks for up to 8 cycles while Neulapeg will be administered within 24-72 hours of the end of dosing and will be available for up to 8 cycles only The crossover control arm will continue as usual
8 The modified FOLFIRINOX chemotherapy regimen will be administered at the original dose at the start of Cycle 1 with subsequent dose deferral until recovery of a neutrophil count 1000 mm3 in the event of toxicity with dose reduction at the discretion of the investigator
2 Patients assigned to the arm receiving prophylactic Neulapeg will receive Neulapeg subcutaneously 24 hours after the end of modified FOLFIRINOX dosing This should be administered no later than 72 hours and Neulapeg will only be given for a maximum of 8 cycles
3 Patients in both arms will have additional visits at the discretion of the investigator for hematologic toxicity surveillance on days 7-10 of modified FOLFIRINOX dosing during the first 4 cycles Thereafter patients will be seen only at the time of chemotherapy administration at the discretion of the investigator
4 Patients in both arms will be instructed to return for any fever greater than 383 degrees Celsius or greater than 380 degrees Celsius lasting more than 1 hour
5 Patients assigned to the arm not receiving prophylactic Neulapeg will not receive intervention with G-CSF for neutropenia of grade 2 or less
6 Patients assigned to the no prophylactic Neulapeg arm will be crossover to prophylactic Neulapeg if they develop Grade 3-4 neutropenia or neutropenic fever Crossover subjects will receive up to 8 cycles of prophylactic Neulapeg as a secondary treatment regardless of starting cycle
7 Hematologic toxicity monitored every cycle for 8 cycles Quality of life assessed according to EORTC QLQ-C30 at baseline once every 2 weeks for a total of 5 times Baseline Cycle 2 Day 1 Cycle 4 Day1 Cycle 6 Day 1 Cycle 8 Day 1 completion of the bone pain questionnaire at baseline once every 1 cycle for the first 4 cycles and then every 2 cycles for a total of 7 times Baseline Cycle 1 Day 1 Cycle 2 Day 1 Cycle 3 Day 1 Cycle 4 Day 1 Cycle 6 Day 1 Cycle 8 Day 1 The mFOLFIRINOX will be administered every 2 weeks for up to 8 cycles while Neulapeg will be administered within 24-72 hours of the end of dosing and will be available for up to 8 cycles only The crossover control arm will continue as usual
8 The modified FOLFIRINOX chemotherapy regimen will be administered at the original dose at the start of Cycle 1 with subsequent dose deferral until recovery of a neutrophil count 1000 mm3 in the event of toxicity with dose reduction at the discretion of the investigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None