Trifluridine/Tipiracil and Irinotecan for the Treatment of Advanced Refractory Biliary Tract Cancer

Conditions

• Advanced 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Irinotecan — DRUG
  Given IV
• Irinotecan Hydrochloride — DRUG
  Given IV
• Trifluridine and Tipiracil Hydrochloride — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Oct 18, 2019

Status verified

Jul 2023

Primary completion

Aug 13, 2021

Completion

Aug 13, 2021

Study Design

Enrollment

28 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (trifluridine and tipiracil, irinotecan)
  Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and irinotecan hydrochloride IV over 90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 16 weeks ]

Locations (1)

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