Phase II Study of Advanced Biliary Tract Cancer Treatment (Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan)
A
Amikar Sehdev, MD
Primary Investigator
Overview
The purpose of the trial is to see whether the combination of 3 drugs (fluorouracil, leucovorin, and nanoliposomal irinotecan) is effective at killing cancer in patients with biliary tract cancer that is unable to be surgical removed or has spread to other parts of the body.
Description
Researchers will complete screening to ensure that it is safe for potential participants to join the study. Screening will include review of medical history and medications, physical exam, measurement of vital signs, blood samples, questionnaires regarding daily activity, CT and/or MRI scans.
If eligible, participants will then begin treatment.
Participants will be asked to complete a follow-up visit every 2 weeks while enrolled in the study. These visits will include discussion with the doctor about any potential side effects, a physical exam, blood tests, and receiving treatment in the clinic.
CT and/or MRI scans will be repeated every 8 weeks while receiving treatment.
Participants will continue to receive treatment until they are taken off the study or no longer wish to participate. Participants will be asked to see the study doctor for a follow-up exam at least once after stopping treatment, and may be contacted every 3 months from then on.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
cancer, biliary tract cancer, biliary tract
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Age: Between 18 Years - 100 Years
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Gender: All
Individuals at least 18 years of age with advanced biliary tract cancer
Women who are pregnant or breastfeeding will not be eligible.
Individuals with a history of acute coronary syndromes, uncontrolled heart disease or clinically significant liver disease, or cardiomyopathy, will not be eligible.
Updated on
26 Apr 2024.
Study ID: 1911793068
