Combination Chemotherapy for Biliary Tract Cancer
Trial Summary
What is the purpose of this trial?
This trial is testing a new combination of three drugs for patients with advanced biliary tract cancers who did not respond well to their first treatment. The drugs work together to damage the cancer cells' DNA and stop them from growing. The goal is to find a better second-line treatment for these patients. Previous tests with similar drugs did not show improvement.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot have had anti-cancer treatment within 3 weeks before enrolling, and you must avoid strong CYP3A4 inducers, inhibitors, or strong UGT1A1 inhibitors within 2 weeks of starting the study.
What data supports the idea that Combination Chemotherapy for Biliary Tract Cancer is an effective treatment?
The available research shows that using a combination of drugs, including liposomal irinotecan, fluorouracil, and leucovorin, can be effective for treating advanced biliary tract cancer. In one study, this combination helped control the disease in about 54.5% of patients and extended their lives by an average of 12.4 months after starting the treatment. Another study, the NIFTY trial, confirmed the benefits of this combination for patients whose cancer had worsened after initial treatments. These results suggest that this combination therapy can be a promising option for patients with advanced biliary tract cancer.12345
What safety data is available for the chemotherapy treatment for biliary tract cancer?
The safety data for the combination chemotherapy treatment involving liposomal irinotecan (nal-IRI), fluorouracil (5-FU), and leucovorin (LV) for biliary tract cancer shows an acceptable safety profile. The NIFTY trial and other studies have demonstrated its efficacy and tolerability as a second-line treatment. In the NIFTY trial, the combination was used for patients with advanced biliary tract cancer, showing promising results. A retrospective analysis at the University Hospital Cologne reported a disease control rate of 54.5% with 3 grade III toxicities. Overall, the treatment demonstrated promising antitumor potential with manageable safety concerns, justifying further investigation in randomized controlled trials.12346
Is the drug used in the trial 'Combination Chemotherapy for Biliary Tract Cancer' a promising treatment?
Yes, the drug combination used in the trial shows promise because it aims to improve the effectiveness and tolerance of chemotherapy for biliary tract cancer, which is known for having a poor prognosis. Various studies have explored different combinations of drugs like 5-fluorouracil, cisplatin, gemcitabine, and others, showing potential in improving patient outcomes.25678
Research Team
Benjamin Weinberg, MD
Principal Investigator
Georgetown University
Eligibility Criteria
This trial is for adults with advanced biliary tract cancers who've had disease progression after gemcitabine and platinum chemotherapy. They should have only received one prior chemotherapy line, be in good physical condition (ECOG 0-1), and not have central nervous system metastases or severe infections recently. Pregnant women, those with certain allergies or liver diseases, and patients on strong drug inhibitors are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nanoliposomal irinotecan, leucovorin, and fluorouracil as second-line treatment for advanced biliary tract cancers
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fluorouracil (Anti-metabolites)
- Leucovorin (Other)
- Nanoliposomal Irinotecan (Topoisomerase I inhibitors)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgetown University
Lead Sponsor
Ipsen
Industry Sponsor