At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 28 enrolled
Drug / intervention
Irinotecan +2 moredrug
Likely dose
Not stated in record
Key inclusion· 9
- ✓Histologically confirmed advanced biliary tract cancer (gallbladder, bile duct) who have received at least one prior line of systemic anticancer therapy
- ✓Patients may have progressed on or be intolerant to prior therapy
- ✓Measurable disease by RECIST criteria (excluding previously irradiated areas and disease measurable by physical exam only)
- ✓ECOG performance status 0 or 1
Key exclusion· 10
- ✕Pregnant or nursing persons
- ✕Persons of childbearing potential unwilling to use adequate contraception for at least 3 months after last dose of study drug
- ✕Severe co-morbid systemic illnesses or concurrent disease that would make patient inappropriate for entry or interfere with safety and toxicity assessment
- ✕Immunocompromised patients or HIV-positive patients currently receiving antiretroviral therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Trifluridine/Tipiracil in Combination With Irinotecan in Biliary Tract Cancers
In Brief
A Phase 2 clinical trial evaluating Irinotecan, Irinotecan Hydrochloride, and 1 other intervention for Advanced Bile Duct Carcinoma and 17 related conditions. Completed, enrolled 28 participants across 1 site.
Detailed Summary
This phase II trial studies how well trifluridine/tipiracil and irinotecan work in treating patients with biliary tract cancer that has spread to other places in the body (advanced) and has not responded to treatment (refractory). Trifluridine/tipiracil and irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Bile Duct Carcinoma, Advanced Gallbladder Carcinoma, Refractory Bile Duct Carcinoma, Refractory Gallbladder Carcinoma, Stage III Distal Bile Duct Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8, Stage III Intrahepatic Bile Duct Cancer AJCC v8, Stage IIIA Distal Bile Duct Cancer AJCC v8, Stage IIIA Gallbladder Cancer AJCC v8, Stage IIIA Intrahepatic Bile Duct Cancer AJCC v8, Stage IIIB Distal Bile Duct Cancer AJCC v8, Stage IIIB Gallbladder Cancer AJCC v8, Stage IIIB Intrahepatic Bile Duct Cancer AJCC v8, Stage IV Distal Bile Duct Cancer AJCC v8, Stage IV Gallbladder Cancer AJCC v8, Stage IV Intrahepatic Bile Duct Cancer AJCC v8, Stage IVA Gallbladder Cancer AJCC v8, Stage IVB Gallbladder Cancer AJCC v8
CountriesUnited States
CollaboratorsNational Comprehensive Cancer Network
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartOct 2019
Primary CompletionAug 2021
TodayJul 2026
First PostedAug 28, 2019
Enrollment StartOct 18, 2019
Primary CompletionAug 13, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.8 years ago
Interventions
Irinotecandrug
Given IV
Irinotecan Hydrochloridedrug
Given IV
Trifluridine and Tipiracil Hydrochloridedrug
Given PO