A Phase II Trial of Trifluridine/Tipiracil Plus Oxaliplatin in Patients With Advanced or Metastatic Biliary Tract Cancer Following First-Line Therapy
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).
• 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 currently available on the use of FTD/TPI in individuals ≤18 years of age, children are excluded from this study.
• Performance status: ECOG performance status of 0 or 1.
• At least one index lesion is measurable based on RECIST 1.1.
• Participants must have organ and marrow function as defined below:
‣ Absolute neutrophil count ≥ 1,500/mcL
⁃ Platelet count ≥75,000/mcL
⁃ AST (SGOT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases
⁃ ALT (SGPT) ≤ 2.5 X institutional upper limit of normal or ≤ 5 × ULN for participants with liver metastases
⁃ Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for participants with bilirubin levels \>1.5 x ULN
⁃ Serum Creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥60 mL/min for participants with creatinine levels \>1.5 x ULN (Cockcroft-Gault method)
• Participants must have recovered adequately from any major surgery, prior to starting therapy.
• Participants must have the ability to understand and the willingness to sign a written informed consent document.
• Agree to use adequate method of contraception.