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Monitoring and Managing Glucose Levels in People With Pancreatic Cancer (PEGASUS)

Primary Purpose

Pancreatic Cancer, PDAC - Pancreatic Ductal Adenocarcinoma, Hyperglycemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endocrinologist-directed target blood glucose level 4-10 mmol/L using data from a continuous glucose monitor (CGM)
Standard Care
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring FOLFIRINOX, Continuous Glucose Monitor, Feasibility, Glycemic management, Endocrinologist, Intensive glucose intervention, Pilot, Glucose control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).
  • Planned to undergo first-line systemic therapy with FOLFIRINOX.
  • Age greater than or equal to 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

  • Adequate bone marrow and organ function as defined by the following laboratory values:

    1. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L.
    2. Platelet count greater than or equal to 75 x 10^9/L.
    3. Hemoglobin greater than or equal to 9.0 g/dL.
    4. Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min.
    5. Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gault formula.
    6. Potassium within normal limits, or corrected with supplements.
    7. International normalized ratio (INR) less than or equal to 1.5.
    8. Total serum bilirubin less than or equal to 2 x upper limit of normal (ULN) (any elevated bilirubin should be asymptomatic at enrollment) except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin less than or equal to 3 x ULN or direct bilirubin less than or equal to 1.5 x ULN).
    9. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (or less than or equal to 5 x ULN if liver metastases are present).
  • Able to understand and voluntarily sign the informed consent form.
  • Able to comply with the study visit schedule and other protocol requirements.
  • Able to swallow oral medications and has no contraindications to subcutaneous insulin injections.
  • Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at baseline.
  • Life expectancy of more than 90 days as judged by the study doctor.

Exclusion Criteria:

  • Absence of distant or lymph node metastases. Participants with borderline resectable or locally advanced PDAC are not eligible.
  • Received prior systemic therapy (chemotherapy or any other anti-cancer agent) for treatment of metastatic PDAC. Participants who received adjuvant chemotherapy after surgical resection of early stage disease are eligible.
  • Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent).
  • Not fit for combination chemotherapy as judged by the study doctor.
  • Presence of brain metastases.
  • Known diagnosis of type I diabetes where strict glucose control and close Endocrinology follow-up is already indicated.
  • Known diagnosis of type II diabetes and already followed by Endocrinologist.
  • Female participants with a positive pregnancy test.
  • Participants who are not safe to include in the study as judged by the study doctor for any medical or non-medical reason.
  • Unable to comply with study assessments and follow-up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Intensive Glucose Intervention

    Standard Care

    Arm Description

    Participants will receive standard anti-hyperglycemic treatment as guided by an endocrinologist using a combination of data from a continuous glucose monitor (CGM) and standard blood work drawn prior to each cycle of chemotherapy. Treatment will aim to maintain glucose levels between 4 and 10 mmol/L. Participants will have real-time access to their glucose data via the CGM.

    Participants will receive standard anti-hyperglycemic treatment only if blood glucose level is above 15 mmol/L as measured from standard blood work drawn prior to each cycle of chemotherapy. Participants will wear a CGM but will not be able to view their glucose data. Participants may be referred to an endocrinologist at the discretion of their medical oncologist.

    Outcomes

    Primary Outcome Measures

    Frequency of glucose levels maintained within range in Arm 1 compared to Arm 2
    The percentage of time each participant's glucose levels in Arm 1 and Arm 2 remained within the 4-10 mmol/L range during the fourth cycle of FOLFIRINOX treatment as measured by a continuous glucose monitor.

    Secondary Outcome Measures

    Overall response rate (ORR) in each study arm, as defined by RECIST 1.1
    The proportion of participants in each study arm who have a complete response (CR) or partial response (PR) to FOLFIRINOX treatment, as defined by RECIST 1.1.
    Progression-free survival (PFS) in each study arm from the initiation of FOLFIRINOX
    The length of time from the first dose of FOLFIRINOX until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm.
    Overall survival (OS) in each study arm from the initiation of FOLFIRINOX
    The length of time from the initiation of FOLFIRINOX that participants survive in each study arm.

    Full Information

    First Posted
    November 10, 2021
    Last Updated
    August 2, 2023
    Sponsor
    British Columbia Cancer Agency
    Collaborators
    University of British Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05132244
    Brief Title
    Monitoring and Managing Glucose Levels in People With Pancreatic Cancer
    Acronym
    PEGASUS
    Official Title
    Pancreatic Cancer Glucose Assessment and Regulation Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2025 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    British Columbia Cancer Agency
    Collaborators
    University of British Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will investigate whether or not it is feasible to closely monitor and manage glucose levels in people with pancreatic cancer. It will also investigate what impact glucose management may have on pancreatic cancer. This is a pilot study that will use continuous glucose monitors (CGM) to monitor glucose levels in approximately 50 participants with pancreatic cancer. Participants will receive standard chemotherapy with a combination of up to four drugs to treat their pancreatic cancer: oxaliplatin, irinotecan, 5-fluorouracil, and leucovorin (FOLFIRINOX). To treat high glucose levels, participants will be randomly assigned to one of two groups: Group 1 will receive anti-hyperglycemic treatment as guided by an endocrinologist with the aim of maintaining glucose levels between 4 and 10 mmol/L; Group 2 will receive anti-hyperglycemic treatment if their glucose levels are above 15 mmol/L, which is standard care. Participants in both Groups 1 and 2 will receive standard anti-hyperglycemic treatments: metformin, insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose co-transporter (SGLT2) inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors. After 4 cycles of FOLFIRINOX, the CGM will be removed but any anti-hyperglycemic treatments will continue as needed. If participants discontinue treatment with FOLFIRINOX, they will continue to be followed for survival and subsequent anti-cancer therapy and will continue follow-up for glucose-related concerns at the discretion of their endocrinologist and/or medical oncologist.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer, PDAC - Pancreatic Ductal Adenocarcinoma, Hyperglycemia
    Keywords
    FOLFIRINOX, Continuous Glucose Monitor, Feasibility, Glycemic management, Endocrinologist, Intensive glucose intervention, Pilot, Glucose control

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Participants in Group 1 can view their glucose data in real-time from the continuous glucose monitor (CGM) whereas participants in Group 2 cannot. Participants in Groups 1 and 2 will NOT be masked to the anti-cancer or anti-hypertensive treatment they receive.
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intensive Glucose Intervention
    Arm Type
    Experimental
    Arm Description
    Participants will receive standard anti-hyperglycemic treatment as guided by an endocrinologist using a combination of data from a continuous glucose monitor (CGM) and standard blood work drawn prior to each cycle of chemotherapy. Treatment will aim to maintain glucose levels between 4 and 10 mmol/L. Participants will have real-time access to their glucose data via the CGM.
    Arm Title
    Standard Care
    Arm Type
    Other
    Arm Description
    Participants will receive standard anti-hyperglycemic treatment only if blood glucose level is above 15 mmol/L as measured from standard blood work drawn prior to each cycle of chemotherapy. Participants will wear a CGM but will not be able to view their glucose data. Participants may be referred to an endocrinologist at the discretion of their medical oncologist.
    Intervention Type
    Procedure
    Intervention Name(s)
    Endocrinologist-directed target blood glucose level 4-10 mmol/L using data from a continuous glucose monitor (CGM)
    Intervention Description
    Standard anti-hyperglycemic treatment given as directed by an endocrinologist to maintain blood glucose level within 4-10 mmol/L based on data from a continuous glucose monitor (CGM) and standard blood work drawn prior to each cycle of chemotherapy. Participants will have access to their glucose data from the CGM.
    Intervention Type
    Other
    Intervention Name(s)
    Standard Care
    Intervention Description
    Standard anti-hyperglycemic treatment given only if blood glucose level is greater than 15 mmol/L as measured from standard blood work drawn prior to each cycle of chemotherapy. Participants will wear a continuous glucose monitor (CGM) but will not have access to their glucose data. Participants may be referred to an endocrinologist at the discretion of their medical oncologist.
    Primary Outcome Measure Information:
    Title
    Frequency of glucose levels maintained within range in Arm 1 compared to Arm 2
    Description
    The percentage of time each participant's glucose levels in Arm 1 and Arm 2 remained within the 4-10 mmol/L range during the fourth cycle of FOLFIRINOX treatment as measured by a continuous glucose monitor.
    Time Frame
    From the Cycle 4 FOLFIRINOX treatment date to the Cycle 5 FOLFIRINOX treatment date (each cycle is typically 14 days).
    Secondary Outcome Measure Information:
    Title
    Overall response rate (ORR) in each study arm, as defined by RECIST 1.1
    Description
    The proportion of participants in each study arm who have a complete response (CR) or partial response (PR) to FOLFIRINOX treatment, as defined by RECIST 1.1.
    Time Frame
    From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
    Title
    Progression-free survival (PFS) in each study arm from the initiation of FOLFIRINOX
    Description
    The length of time from the first dose of FOLFIRINOX until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm.
    Time Frame
    From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
    Title
    Overall survival (OS) in each study arm from the initiation of FOLFIRINOX
    Description
    The length of time from the initiation of FOLFIRINOX that participants survive in each study arm.
    Time Frame
    From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.
    Other Pre-specified Outcome Measures:
    Title
    Overall response rate (ORR) in each study arm, as defined by RECIST 1.1 and stratified by prognostic and metabolic gene expression subtypes of PDAC
    Description
    The proportion of participants in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC who have a complete response (CR) or partial response (PR) to FOLFIRINOX treatment, as defined by RECIST 1.1.
    Time Frame
    From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
    Title
    Progression-free survival (PFS) in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of FOLFIRINOX
    Description
    The length of time from the first dose of FOLFIRINOX until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC.
    Time Frame
    From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
    Title
    Overall survival (OS) in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of FOLFIRINOX
    Description
    The length of time from the initiation of FOLFIRINOX that participants survive in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC.
    Time Frame
    From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.
    Title
    Overall response rate (ORR) in each study arm, as defined by RECIST 1.1 and stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles
    Description
    The proportion of participants in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles who have a complete response (CR) or partial response (PR) to FOLFIRINOX treatment, as defined by RECIST 1.1.
    Time Frame
    From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
    Title
    Progression-free survival (PFS) in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles from the initiation of FOLFIRINOX
    Description
    The length of time from the first dose of FOLFIRINOX until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles.
    Time Frame
    From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.
    Title
    Overall survival (OS) in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles from the initiation of FOLFIRINOX
    Description
    The length of time from the initiation of FOLFIRINOX that participants survive in each study arm stratified by clinical features (i.e. type 2 diabetes), pathological profiles, and genomic profiles.
    Time Frame
    From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.
    Title
    Amount of insulin, measured in molar, for participants in each study arm from screening until the end of study visit
    Description
    The quantity of insulin, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.
    Time Frame
    From the date of screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).
    Title
    Amount of proinsulin, measured in molar, for participants in each study arm from screening until the end of study visit
    Description
    The quantity of proinsulin, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.
    Time Frame
    From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).
    Title
    Amount of C-peptide, measured in molar, for participants in each study arm from screening until the end of study visit
    Description
    The quantity of C-peptide, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.
    Time Frame
    From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).
    Title
    Amount of circulating biomarkers, measured in molar, for participants in each study arm from screening until the end of study visit
    Description
    The quantity of circulating biomarkers, measured in molar from immunoassays, from blood samples collected throughout the study for the participants in each study arm.
    Time Frame
    From the date of the screening blood sample collection until the date of the end of study blood sample collection (an average of 6 months).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC). Planned to undergo first-line systemic therapy with FOLFIRINOX. Age greater than or equal to 18 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Adequate bone marrow and organ function as defined by the following laboratory values: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L. Platelet count greater than or equal to 75 x 10^9/L. Hemoglobin greater than or equal to 9.0 g/dL. Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min. Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gault formula. Potassium within normal limits, or corrected with supplements. International normalized ratio (INR) less than or equal to 1.5. Total serum bilirubin less than or equal to 2 x upper limit of normal (ULN) (any elevated bilirubin should be asymptomatic at enrollment) except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin less than or equal to 3 x ULN or direct bilirubin less than or equal to 1.5 x ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (or less than or equal to 5 x ULN if liver metastases are present). Able to understand and voluntarily sign the informed consent form. Able to comply with the study visit schedule and other protocol requirements. Able to swallow oral medications and has no contraindications to subcutaneous insulin injections. Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at baseline. Life expectancy of more than 90 days as judged by the study doctor. Exclusion Criteria: Absence of distant or lymph node metastases. Participants with borderline resectable or locally advanced PDAC are not eligible. Received prior systemic therapy (chemotherapy or any other anti-cancer agent) for treatment of metastatic PDAC. Participants who received adjuvant chemotherapy after surgical resection of early stage disease are eligible. Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent). Not fit for combination chemotherapy as judged by the study doctor. Presence of brain metastases. Known diagnosis of type I diabetes where strict glucose control and close Endocrinology follow-up is already indicated. Known diagnosis of type II diabetes and already followed by Endocrinologist. Female participants with a positive pregnancy test. Participants who are not safe to include in the study as judged by the study doctor for any medical or non-medical reason. Unable to comply with study assessments and follow-up.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Daniel Renouf, MD, MPH
    Phone
    604-877-6000
    Ext
    672445
    Email
    drenouf@bccancer.bc.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel Renouf, MD, MPH
    Organizational Affiliation
    BC Cancer
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

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