A phase II study to evaluate the efficacy of liposomal irinotecan in combination with oxaliplatin, leucovorin, and 5-fluorouracil for patients with locally advanced pancreatic carcinoma: Big Ten Cancer Research Consortium BTCRC-GI15-067
Overview
The purpose of this voluntary research study is to see if using four drugs called liposomal irinotecan, 5FU, leucovorin and oxaliplatin as a first line treatment can improve outcomes for patients with locally advanced pancreatic carcinoma (pancreatic cancer).
Description
Participants will begin with screening, to include: medical history review, physical exam, ECG, blood tests, radiology imaging. During visit 1, participants will then repeat physical exam, questionnaire, and blood tests, as well as tissue collection and infusions of FOLFOX and liposomal irinotecan. Participants will take the infusion pump home, wear it for 2 days, and then return to IU Health to have the pump removed.
Participants will repeat a physical exam every 2 weeks, blood tests every 4 weeks, and radiology imaging every 8 weeks. Participants will take study drugs until cancer can be removed by surgery, cancer gets worse, or they have severe side effects. Approximately 1 month after finishing study drugs, participants will complete a questionnaire, blood tests, and physical exam.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
2010106646, pancreatic carcinoma
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Age: Between 18 Years - 100 Years
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Gender: All
Individuals at least 18 years of age with histological or cytological confirmation of pancreatic carcinoma.
Individuals with pre-existing peripheral neuropathy, active uncontrolled cardiac arrhythmia or congestive heart failure, history or myocardial infarction, unstable angina, acute coronary syndrome, or HIV will not be eligible.
Individuals who have undergone major surgery within 4 weeks will not be eligible.
Women who are pregnant or breastfeeding will not be eligible.
Updated on
26 Apr 2024.
Study ID: 2010106646
