Hyperglycemia, Pancreatic Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
Glycemic management, Prevalence of hyperglycemia, Blood draws, Standard treatments, First-line systemic therapy
Brief summary
This study will investigate the prevalence of hyperglycemia (high blood sugar) in approximately 50 participants with pancreatic cancer. Sugar levels will be monitored with blood draws prior to each cycle of anti-cancer treatment until treatment ends or the participant's cancer worsens. Participants may receive any first-line systemic therapy for pancreatic cancer, including treatments given as part of another clinical trial. If treatment is needed to manage blood sugar levels, the treatment will be given according to the standard of care. All participants will be enrolled into the same group.
Interventions
PROCEDUREGlucose Measurements via Blood Draw
Blood glucose levels will be measured using blood drawn prior to each cycle of systemic therapy. Anti-cancer treatment can follow standard care protocols or be given within another clinical trial. Anti-hyperglycemic treatment will be administered when indicated by and following standard care protocols.
Sponsors
British Columbia Cancer Agency
University of British Columbia
Lustgarten Foundation
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC). * Planned to undergo first-line systemic therapy. * 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. * 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). * 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who experience at least one episode of hyperglycemia | From baseline (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months. | The proportion of participants who experience at least one episode of hyperglycemia. Hyperglycemia is defined by standard non-fasting criteria: random plasma glucose greater than or equal to 11.1 mmol/L or hemoglobin A1c greater than or equal to 6.5%. |
| Percentage of glucose measurements above the target range | From baseline (up to 2 weeks prior to first dose) until progression of disease, assessed up to 24 months. | The percentage of random plasma glucose measurements that are greater than or equal to 11.1 mmol/L or hemoglobin A1c measurements that are greater than or equal to 6.5%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) of the cohort, as defined by RECIST 1.1 | From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, assessed up to 24 months. | The proportion of participants who have a complete response (CR) or partial response (PR) to first-line systemic therapy, as defined by RECIST 1.1. |
| Progression-free survival (PFS) of the cohort from the initiation of first-line systemic therapy | From the date of first dose of first-line systemic therapy until the date of confirmed progression, assessed up to 24 months. | The length of time from the first dose of first-line systemic therapy until the date of progressive disease (PD), as defined by RECIST 1.1. |
| Overall survival (OS) of the cohort from the initiation of first-line systemic therapy | From the date of first dose of first-line systemic therapy until the date of death or end of study, assessed up to 24 months. | The length of time from the initiation of first-line systemic therapy that participants survive. |
Countries
Canada
Contacts
CONTACTDaniel Renouf, MD, MPH
PRINCIPAL_INVESTIGATORDaniel Renouf, MD, MPH
BC Cancer
Outcome results
None listed