UT Health San Antonio

Eligibility

Eligible Ages

Over 70 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

- Newly diagnosed untreated metastatic adenocarcinoma of the pancreas. However,
previous surgery, adjuvant chemotherapy and/or radiation therapy will be allowed,
provided radiation therapy is completed at least 2 weeks prior to registration and
adjuvant therapy was administered more than 6 months prior to registration. Patients
with the following histology are excluded: acinar cell; adenosquamous carcinoma

- 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 registration)

- Absolute neutrophil count >= 1,500/mcL (obtained within 4 weeks of registration)

- Platelets >= 100,000/mcL (obtained within 4 weeks of registration)

- Total bilirubin =< institutional upper limit of normal (ULN) (obtained within 4
weeks of registration)

- 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 registration)

- Creatinine =< institutional ULN unless data exists supporting safe use at lower
kidney function values, no lower than 30 mL/min/1.73 m^2 (obtained within 4 weeks of
registration)

- Glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2 unless data exists supporting
safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2 (obtained
within 4 weeks of registration)

- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months of registration 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

- Male patients must agree not to father children while on study

- 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 2B or better

- Patients must have measurable disease and scans must be done within 4 weeks of
registration

- 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 must agree not to take 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