Study on Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan for Advanced Biliary Cancer

Sponsor: Georgetown University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04005339

Provider View

This clinical trial is testing a combination of three drugs—fluorouracil, leucovorin, and nanoliposomal irinotecan—as a second treatment option for patients with advanced biliary tract cancers who have already received gemcitabine and platinum chemotherapy.

Patient Parameters

Program Overview

The purpose of this study is to see how well a combination of three drugs—fluorouracil, leucovorin, and nanoliposomal irinotecan—works as a second treatment for patients with advanced biliary tract cancers. These patients have already been treated with gemcitabine and platinum chemotherapy. The study will take place at multiple centers and will involve regular check-ups and imaging tests every 8 weeks to monitor the cancer's response to the treatment.

Description

This study is designed to evaluate the effectiveness of a drug combination for patients with advanced biliary tract cancers, such as cholangiocarcinoma or gallbladder cancer, that cannot be removed by surgery or have spread to other parts of the body. Patients who have already been treated with gemcitabine and platinum chemotherapy and meet certain health criteria can participate. The study will involve taking the drug combination and undergoing regular imaging tests to see how the cancer responds. Patients can continue in the study as long as they tolerate the treatment well and the cancer does not progress.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with biliary tract cancer (cholangiocarcinoma or gallbladder cancer) that cannot be surgically removed or has spread.
  • Cancer has worsened after or cannot tolerate previous treatment with gemcitabine and platinum-based chemotherapy.
  • Have not received more than one prior chemotherapy treatment for advanced cancer (previous adjuvant therapy does not count).
  • Have measurable cancer according to specific medical criteria.
  • Be in good overall health with a performance status score of 0 or 1.
  • Be at least 18 years old.
  • HIV-positive patients can participate if they have a stable treatment regimen, no need for preventive antibiotics or antifungals, a CD4 count above 250, and an undetectable viral load.
  • Have adequate bone marrow, liver, and kidney function.
  • Agree to provide a sample of previous tumor tissue if available (not required for participation).

Exclusion Criteria

  • Have ampullary adenocarcinoma.
  • Are pregnant or breastfeeding.
  • Have received any anti-cancer treatment within 3 weeks before joining the study.
  • Have previously been treated with irinotecan or nanoliposomal irinotecan.
  • Have cancer that has spread to the brain unless it has been stable for at least 4 weeks and no need for steroids for at least 2 weeks.
  • Have used certain strong medications affecting liver enzymes within 2 weeks of starting the study.
  • Have another active cancer or had another cancer within the last 3 years, except for certain skin, prostate, or cervical cancers.
  • Have a bowel obstruction.
  • Are allergic to any of the study drugs.
  • Have significant liver disease, unless hepatitis B or C has been resolved.
  • Have had severe infections within 4 weeks before joining the study.
  • Have had major surgery within 4 weeks before joining the study.

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