A Phase II Trial of Trifluridine/Tipiracil Plus Oxaliplatin in Patients With Advanced or Metastatic Biliary Tract Cancer Following First-Line Therapy
Case Comprehensive Cancer Center
Summary
Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combination of chemotherapy drugs called FOLFOX which consists of fluorouracil and oxaliplatin. Studies have shown that other treatments may work better to treat advanced BTC. In this study, investigators want to see if treating patients with the drug combination of trifluridine/tipiracil (FTD/TPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD/TPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).
Description
BTCs are difficult to treat. It is estimated that in the United States (US) approximately 15,000-20,000 people will be diagnosed with a BTC per year. In 2024, liver and intrahepatic bile duct cancers were the 5th leading cause of death from cancer among men and 7th among women in the US (1). Most people with BTCs have cancer that has spread or cannot be removed with surgery, so systemic treatments are the only option. However, the median survival after being diagnosed with an advanced BTC is still only 4.5 months, so it is important that we find better treatment options (2). This study is eva…
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically or cytologically confirmed biliary tract cancer (BTC) including cholangiocarcinoma and gallbladder carcinoma. Individuals with ampullary cancers will not be considered eligible. Cancer must be advanced stage or metastatic. * Participants must have received only one line of systemic therapy for advanced or metastatic BTCs. * Note: Individuals who have either progressed or are intolerant to the prior therapy can be included in this study. * Age \>18 years on day of signing informed consent. Because no dosing or adverse event data are c…
Interventions
- DrugTrifluridine/tipiracil
FTD/TPI will be taken by mouth on Days 1-5 of the 14-day treatment cycle. The starting does is 25mg/m2 twice per day.
- DrugOxaliplatin
Oxaliplatin is given on Day 1 of each 14-day cycle. It is given intravenously (by IV) over 2 hours.
Locations (2)
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio
- Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio