drugset / Trial / NCT02720601

Irinotecan and Capecitabine as Second-line Treatment for Advanced/Metastatic Biliary Tract Cancers

NCT02720601 ↗

NaSingle-groupOpen-labelTreatment

Summary

Biliary tract cancers that progress after first line treatment can be difficult to treat. There is a great need for an effective, tolerable, easy to administer second-line regimen. Previous early phase studies demonstrated that the combination of two chemotherapy drugs, irinotecan and capecitabine had activity in this setting. The goal of this study is to determine whether this drug combination, as a second-line treatment, can improve progression free survival in patients with biliary tract cancers.

Timeline

Start
2015-11
Primary completion
2018-03
Completion
2020-03

Outcome

Outcome not reported

Stopped: “Study was never submitted to the IRB \& never opened. PI is leaving institution.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1500 mg/m2 Oral
Subject Irinotecan Small molecule 120 mg/m2 Intravenous

Indications