NCT04005339

NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer

NAPOLI-2: Phase II Study of Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Previously Treated Advanced Biliary Tract Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy.

Detailed description

This is a single arm, open label, multicenter phase II study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy. Patients with advanced biliary tract cancers who have adequate performance status and adequate hepatic and renal function will be eligible. Patients may have received adjuvant chemotherapy and/or radiation therapy prior to enrolling in the trial, but a minimum of 6 months between adjuvant chemotherapy and this current therapy are required. Patients may continue on study as long as they are tolerating treatment and do not have progression of disease by RECIST v1.1 criteria. Response assessments will occur using imaging (CT or MRI) every 8 weeks.

Conditions

• Advanced Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Nanoliposomal Irinotecan	Nanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days
DRUG	Leucovorin	Leucovorin 400 mg/ IV over 30 minutes, every 14 days.
DRUG	Fluorouracil	Fluorouracil 2,400 mg/m IV over 46 hours.

Timeline

• Start date: 2019-07-29
• Primary completion: 2025-09-03
• Completion: 2026-12-31
• First posted: 2019-07-02
• Last updated: 2026-01-26

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study