nct04233866

Eligibility

Inclusion Criterea

• Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. If a patient had a biopsy of the pancreatic mass and the clinical picture is consistent with metastatic pancreatic cancer, another biopsy of a metastatic site is not required for this trial. Patients with acinar cell or adenosquamous carcinoma histology are ineligible. Patients with neuroendocrine histology are ineligible
• Patients who have had previous surgery, adjuvant/neoadjuvant chemotherapy and/or radiation therapy will be allowed to enroll, provided therapy was completed at least 6 months prior to randomization. Palliative radiation to a metastatic site prior to study enrollment is allowed
• Patient must be >= 70 years of age
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Patient is an English speaker with the ability to understand and complete the informed consent and questionnaires
• Leukocytes >= 3,000/mcL (obtained within 4 weeks of randomization)
• Absolute neutrophil count >= 1,500/mcL (obtained within 4 weeks of randomization)
• Platelets >= 100,000/mcL (obtained within 4 weeks of randomization)
• Total bilirubin =< institutional upper limit of normal (ULN) (obtained within 4 weeks of randomization)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 4 weeks of randomization)
• Creatinine =< institutional ULN OR glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2 (obtained within 4 weeks of randomization)
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this protocol. HIV positive (+) patients who are on ritonavir or/and cobicistat-based regimen must be switched to alternative anti-retroviral therapy (ART)
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Patients must agree not to father children while on study and for 3 months after the last dose of protocol treatment.
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this protocol, patients should be class 2 or better
• Patients must have measurable disease and scans must be done within 4 weeks of randomization
• Patients classified to have mild-moderate abnormalities in any of the domains evaluated in the screening geriatric assessment and are classified as “vulnerable” are eligible. Patients classified without any abnormalities (“fit”) or with severe cognitive/functional impairment or high co-morbidity score (“frail”) on the screening geriatric assessment are ineligible
• Patients should avoid taking any medications or substances that are strong inhibitors or inducers of CYP3A4. Those who are randomized to liposomal irinotecan treatment arm should avoid drugs that are UGT1A1 inhibitors

Exclusion Criterea