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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT04005339
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 29, 2019
Status verified
Jan 2026
Primary completion
Sep 3, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Nanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days. Leucovorin 400 mg/ IV over 30 minutes, every 14 days. Fluorouracil 2,400 mg/m IV over 46 hours.

Primary Outcome Measure

The efficacy of fluorouracil, leucovorin, and nanoliposomal irinotecan in advanced biliary tract cancers following progression on or intolerance of gemcitabine and platinum chemotherapy. [ Time Frame: 4 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington D.C.District of Columbia20007-
Indiana University Health Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Washington University School of Medicine- Siteman Cancer CenterSt LouisMissouri63110-
Icahn School of Medicine at Mount SinaiNew YorkNew York10128-

Find similar trials in Washington D.C., DC

By research site
Lombardi Comprehensive Cancer Center, Georgetown University· Washington D.C., DCIndiana University Health Melvin and Bren Simon Cancer Center· Indianapolis, INWashington University School of Medicine- Siteman Cancer Center· St Louis, MOIcahn School of Medicine at Mount Sinai· New York, NY

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