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

Description

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.

Conditions

Advanced Biliary Tract Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Biliary Tract Cancer
Intervention / Treatment

-

Contacts and Locations

Washington

Lombardi Comprehensive Cancer Center, Georgetown University, Washington, District of Columbia, United States, 20007

Indianapolis

Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States, 46202

Saint Louis

Washington University School of Medicine- Siteman Cancer Center, Saint Louis, Missouri, United States, 63110

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Georgetown University,

Benjamin Weinberg, MD, STUDY_CHAIR, Georgetown University

Study Record Dates

2025-12-31