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

NCT ID: NCT04005339

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nanoliposomal Irinotecan

Intervention Type: DRUG

Nanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days

Leucovorin

Intervention Type: DRUG

Leucovorin 400 mg/ IV over 30 minutes, every 14 days.

Fluorouracil

Intervention Type: DRUG

Fluorouracil 2,400 mg/m IV over 46 hours.

Interventions

Nanoliposomal Irinotecan

Nanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days

Intervention Type: DRUG

Leucovorin

Leucovorin 400 mg/ IV over 30 minutes, every 14 days.

Intervention Type: DRUG

Fluorouracil

Fluorouracil 2,400 mg/m IV over 46 hours.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pathologically-confirmed biliary tract cancer (cholangiocarcinoma or gallbladder adenocarcinoma), unresectable or metastatic
• Disease progression on or intolerance of gemcitabine- and platinum-based chemotherapy
• No more than 1 prior line of chemotherapy for unresectable or metastatic disease (adjuvant therapy does not count)
• Measurable disease by RECIST v1.1 criteria
• ECOG performance status of 0-1
• At least 18 years of age
• HIV-positive patients are eligible provided: Stable HAART regimen, No concurrent prophylactic antibiotics or antifungals, and CD4 count above 250 and undetectable viral load
• Adequate bone marrow, hepatic, and renal function
• Consent to access archived tumor tissue if available (available tissue is not required for enrollment)

Exclusion Criteria

• Ampullary adenocarcinoma
• Woman who are pregnant or breastfeeding
• Anti-cancer treatment within 3 weeks prior to enrollment
• Prior irinotecan or nanoliposomal irinotecan
• Central nervous system metastases unless stable for at least 4 weeks and at least 2 weeks off corticosteroids
• Exposure to a strong CYP3A4 inducer, strong CYP3A4 inhibitor, or strong UGT1A1 inhibitor within 2 weeks of study start
• Known concurrent malignancy or other malignancy within 3 years except for non-melanomatous skin cancers, prostate or cervical cancers following curative therapy, or superficial bladder cancer
• Bowel obstruction
• Allergy or hypersensitivity to fluoropyrimidines, irinotecan, or nanoliposomal irinotecan
• Clinically significant liver disease: Patients with resolved hepatitis B infection are eligible if HBsAg testing is negative; Patients with resolved hepatitis C infection are eligible if viral RNA PCR is negative
• Severe infections within 4 weeks prior to enrollment
• Major surgery within 4 weeks prior to enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Weinberg, MD

Role: STUDY_CHAIR

Georgetown University

Locations

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, United States

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Washington University School of Medicine- Siteman Cancer Center

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

2018-0877

Identifier Type: -

Identifier Source: org_study_id