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A Study of Glipizide to Treat High Blood Sugar in People with Metastatic Pancreatic Cancer
Trial Status: active
This phase II trial tests how well glipizide works in treating high blood sugar (hyperglycemia) in patients with pancreatic cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Hyperglycemia happens when the body does not make enough insulin, a natural substance that is needed to break down sugar in the body, or does not use insulin the way it should. Hyperglycemia is commonly found in patients with pancreatic cancer. In patients with pancreatic cancer, the cancer sends signals to the pancreas to have it stop producing enough insulin to lower blood sugar and this change in insulin production causes hyperglycemia. Glipizide is in a class of medications called sulfonylureas. Glipizide signals the pancreas to make more insulin, helping the body get rid of excess sugar in the blood. Glipizide may be effective at lowering blood sugar in patients with pancreatic cancer.
Inclusion Criteria
COHORT 1: Age >= 18 years
COHORT 1: Biopsy-proven PDAC
COHORT 1: Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic) willing and able to comply with the requirements of the protocol
COHORT 1: Willing and able to comply with the requirements of the protocol
COHORT 1: Willing to use their bluetooth-enabled wifi or cellular mobile device
COHORT 1: Hemoglobin A1c (glycosylated hemoglobin [HbA1c]) > 7%, or fructosamine > 287 mg/dL, or random glucose > 180 mg/dL, or strong clinical suspicion that patient has hyperglycemia, making it reasonable to expect their mean daily glucose is >= 154 mg/dL
COHORT 1: Eastern Cooperative Oncology Group performance status >= 2
COHORT 1: Body mass index (BMI) < 30 kg/m^2
COHORT 2a: Age >= 18 years
COHORT 2a: Biopsy-proven PDAC
COHORT 2a: Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic pancreatic cancer)
Cohort 2a: Clinical diagnosis of diabetes mellitus
COHORT 2a: Active care at Memorial Sloan Kettering (MSK) (defined as at least 1 physician or advanced practice practitioner [APP] encounter every 3 months) for PDAC during the period from which data were recorded in the electronic medical record (in this retrospective study patients need not be under active care at the time the research is conducted)
COHORT 2a: At least 1 electronic prescription for a sulfonylurea (glipizide, glimepiride, or glyburide) or metformin
COHORT 2a: Three-month baseline period before metformin or sulfonylurea initiation in which the participant does not receive either drug class or insulin
COHORT 2a: Body weight recorded within 3 months before start of metformin or a sulfonylurea
COHORT 2b: Age >= 18 years
COHORT 2b: Biopsy-proven PDAC
COHORT 2b: Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic)
COHORT 2b: Active care at MSK (defined as at least 1 physician or APP encounter every 3 months) for PDAC during the period of data collection
COHORT 2b: Apparent current use based on chart review of metformin (but not sulfonylurea); sulfonylurea (but not metformin); or neither drug
Exclusion Criteria
COHORT 1: Use during the past month of any antidiabetic medication other than metformin at home (sporadic use [fewer than 1 of 7 days during the past month] is permitted)
COHORT 1: Changes in metformin dose in the past month
COHORT 1: History of sulfonylurea intolerance or allergy
COHORT 1: History of severe hypoglycemia (hypoglycemia requiring emergency medical assistance, emergency room or urgent care visit, or hospital admission)
COHORT 1: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal
I. Conduct a single-arm nonrandomized trial to evaluate the hypothesis that glipizide is both effective and safe at lowering glucose in patients undergoing systemic therapy for metastatic pancreatic ductal adenocarcinoma (PDAC). (Cohort 1)
II. Conduct a retrospective cohort study to test the hypothesis that, compared with metformin, sulfonylureas are associated with better weight maintenance in patients undergoing systemic treatment for metastatic PDAC. (Cohort 2a)
SECONDARY OBJECTIVE:
I. Administer a cross-sectional survey to 30 patients to ascertain current medication use; these survey responses will be used as a reference standard to assess the accuracy of chart review data from Cohort 2a. (Cohort 2b)
OUTLINE:
COHORT 1: Patients wear a continuous glucose monitor (CGM) to monitor blood sugar levels for up to 4 months. Patients with high blood sugar levels receive glipizide orally (PO) once daily (QD) or twice daily (BID) for up to 4 months. Patients also undergo blood sample collection at baseline and every 4 weeks throughout study.
COHORT 2a: Patients have medical records reviewed on study.
COHORT 2b: Patients complete a survey to determine medication usage on study.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
