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Combination Chemotherapy for Biliary Tract Cancer
Phase 2
Recruiting
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically-confirmed biliary tract cancer (cholangiocarcinoma or gallbladder adenocarcinoma), unresectable or metastatic
No more than 1 prior line of chemotherapy for unresectable or metastatic disease (adjuvant therapy does not count)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new combination chemotherapy treatment for patients with biliary tract cancer that has progressed after first-line treatment.
Who is the study for?
This trial is for adults with advanced biliary tract cancers who've had disease progression after gemcitabine and platinum chemotherapy. They should have only received one prior chemotherapy line, be in good physical condition (ECOG 0-1), and not have central nervous system metastases or severe infections recently. Pregnant women, those with certain allergies or liver diseases, and patients on strong drug inhibitors are excluded.Check my eligibility
What is being tested?
The NAPOLI-2 study tests a combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as a second-line treatment for biliary cancer following initial chemo. It aims to assess the effectiveness of this regimen in patients whose cancer has progressed despite previous treatments.See study design
What are the potential side effects?
Potential side effects include reactions related to the digestive system like diarrhea and nausea, lowered blood cell counts leading to increased infection risk or bleeding problems, fatigue, hair loss due to irinotecan; hand-foot syndrome from fluorouracil; allergic reactions are also possible.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is in the bile ducts or gallbladder and cannot be surgically removed.
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I have had only one chemotherapy for my advanced cancer.
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My cancer got worse or I couldn't tolerate treatments with gemcitabine and platinum.
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I am HIV-positive, on stable HIV treatment, without needing daily infection-preventing medicine, and my HIV is well-controlled.
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I am fully active or can carry out light work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The efficacy of fluorouracil, leucovorin, and nanoliposomal irinotecan in advanced biliary tract cancers following progression on or intolerance of gemcitabine and platinum chemotherapy.
Secondary outcome measures
Disease control rate (DCR).
Maximum change in tumor marker, CA19-9.
Median duration of disease control (DDC).
+4 moreOther outcome measures
Archived tumor tissue using next-generation sequencing (NGS) and immunohistochemistry (IHC) in order to elucidate potential mutational biomarkers predictive of response to fluorouracil, leucovorin, and nanoliposomal irinotecan.
Blood for the analysis of circulating tumor DNA as a surrogate marker of disease burden.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nanoliposomal Irinotecan
2019
Completed Phase 1
~50
Fluorouracil
2014
Completed Phase 3
~11540
Leucovorin
2005
Completed Phase 4
~5730
Find a Location
Who is running the clinical trial?
IpsenIndustry Sponsor
345 Previous Clinical Trials
73,184 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
64 Patients Enrolled for Cholangiocarcinoma
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,458 Total Patients Enrolled
3 Trials studying Cholangiocarcinoma
45 Patients Enrolled for Cholangiocarcinoma
Benjamin Weinberg, MDStudy ChairGeorgetown University
5 Previous Clinical Trials
153 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blockage in my intestines.My cancer is in the bile ducts or gallbladder and cannot be surgically removed.My liver, kidneys, and bone marrow are functioning well.I have no other cancers except for certain skin, prostate, cervical, or superficial bladder cancers in the last 3 years.I have been diagnosed with cancer of the ampulla of Vater.I have had only one chemotherapy for my advanced cancer.I had hepatitis B or C, but it's now resolved and tests confirm it.My cancer got worse or I couldn't tolerate treatments with gemcitabine and platinum.I am HIV-positive, on stable HIV treatment, without needing daily infection-preventing medicine, and my HIV is well-controlled.My brain metastases have been stable for over a month and I haven't taken corticosteroids in at least 2 weeks.I am fully active or can carry out light work.I haven't had cancer treatment in the last 3 weeks.I am 18 years old or older.I haven't taken strong medication affecting liver enzymes in the last 2 weeks.I am not pregnant or breastfeeding.You are allergic or have a strong reaction to fluoropyrimidines, irinotecan, or nanoliposomal irinotecan.I have previously been treated with irinotecan or its nanoliposomal form.I have not had a severe infection in the last 4 weeks.I have not had major surgery in the last 4 weeks.I agree to provide access to my stored tumor samples, if I have any.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being signed up for this research project?
"That is accurate. As of today, the trial detailed on clinicaltrials.gov is looking for 44 individuals to participate at 3 different sites. The listing was put up on 7/29/2019 and was most recently updated on 8/18/2022."
Answered by AI
What is the standard use for Nanoliposomal Irinotecan?
"Carcinomas of the rectum, colon, and ovaries can all be treated using Nanoliposomal Irinotecan."
Answered by AI
What other drug therapies has Nanoliposomal Irinotecan been studied in conjunction with?
"532 clinical trials for Nanoliposomal Irinotecan are ongoing, with 148 in Phase 3. Most of these studies are located in Shanghai, but there are over 25000 other locations where research is being conducted."
Answered by AI
Can new participants still sign up for this experiment?
"That is accurate. The listing on clinicaltrials.gov says that the trial is open for recruitment and provides additional details: it was first posted on 7/29/2019, edited on 8/18/2022, and is looking for 44 patients at 3 locations."
Answered by AI
When might we see Nanoliposomal Irinotecan available to the public?
"Nanoliposomal Irinotecan is still being tested for efficacy in Phase 2 clinical trials, but there is enough evidence supporting its safety to give it a score of 2."
Answered by AI
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