ACTIVE_NOT_RECRUITING

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

Conditions

Advanced Biliary Tract Cancer Biliary Tract Cancer GI Cancer Biliary Cancer NAPOLI-2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2019-07-29

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04005339

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Benjamin Weinberg, MD

STUDY_CHAIR

Georgetown University

Study Locations (Sites)

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, 20007

United States

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

United States

Washington University School of Medicine- Siteman Cancer Center

St Louis, Missouri, 63110

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10128

United States

Collaborators and Investigators

Sponsor: Georgetown University

Benjamin Weinberg, MD, STUDY_CHAIR, Georgetown University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-29

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2019-07-29

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Advanced Biliary Tract Cancer
Biliary Tract Cancer
GI Cancer
Biliary Cancer
NAPOLI-2

Additional Relevant MeSH Terms

Advanced Biliary Tract Cancer