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Anti-metabolite
Chemotherapy for Pancreatic Neuroendocrine Carcinoma
Phase 2
Waitlist Available
Led By Renuka Iyer
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine =< 1.5 x institutional ULN or measured or calculated creatinine clearance by Cockcroft Gault Equation >= 50ml/min for subjects with creatinine levels > 1.5 x ULN.
Participant must have tissue available for central pathology review and, must have pathologically/histologically confirmed high grade neuro endocrine defined as Ki-67 proliferative index of 20-100% or, must have evidence of at least 10 mitotic figures per 10 high powered fields.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying liposomal irinotecan, leucovorin, and fluorouracil to see how well it works in treating patients with high grade neuroendocrine cancer of gastrointestinal, unknown, or pancreatic origin.
Who is the study for?
This trial is for adults with advanced high grade neuroendocrine cancer of the GI tract, pancreas, or unknown origin that's resistant to treatment and has spread. They must have certain blood cell counts, organ function levels within set limits, a life expectancy of at least 12 weeks, agree to use contraception if applicable, and not be pregnant. Participants need measurable disease per RECIST criteria and can't have untreated brain metastases or certain serious health conditions.Check my eligibility
What is being tested?
The study tests liposomal irinotecan combined with fluorouracil and leucovorin in patients whose cancer hasn't responded to other treatments. It aims to see if this combination can stop tumor growth by blocking enzymes needed for cell growth and spreading. The trial includes quality-of-life assessments as well.See study design
What are the potential side effects?
Potential side effects may include reactions related to chemotherapy such as nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, liver enzyme changes indicating potential liver damage, hair loss (alopecia), mouth sores (mucositis), and hand-foot syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels or clearance, is within the required range.
Select...
My cancer is a high-grade neuroendocrine tumor confirmed by tests.
Select...
I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Secondary outcome measures
Clinical Benefit Response
Incidence of Grade 3+ Treatment Related Adverse Events (TRAE)
Overall Survival
+4 moreOther outcome measures
Molecular profiling for select protein expression biomarker PD-L1
Molecular profiling for select protein expression biomarker TOP2A
molecular profiling for mutations, immune-oncology Will be conducted on all pre-study tumor samples and will be compared to patient treatment outcome.
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (liposomal irinotecan, leucovorin, fluorouracil)Experimental Treatment4 Interventions
Patients receive liposomal irinotecan IV over 90 minutes, leucovorin IV over 30 minutes, and fluorouracil IV over 46 hours on days 1 and 15. Courses repeat every 28 days for in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Leucovorin
2005
Completed Phase 4
~5730
Liposomal Irinotecan
2019
Completed Phase 1
~20
Quality-of-Life Assessment
2017
Completed Phase 3
~4950
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,847 Total Patients Enrolled
IpsenIndustry Sponsor
345 Previous Clinical Trials
73,217 Total Patients Enrolled
Renuka IyerPrincipal InvestigatorRoswell Park Cancer Institute
7 Previous Clinical Trials
196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver enzymes (AST and ALT) are not too high. If you have liver metastases, the enzymes can be a little higher, but not too much.Your hemoglobin level is at least 9 grams per deciliter.You have a low number of white blood cells.I do not have any serious illnesses that would stop me from following the study's requirements.I am using or willing to use effective birth control during the study.My cancer is advanced, cannot be surgically removed, and is not from the lung.I have stable brain metastases, not on steroids for 7 days, and no carcinomatous meningitis.My bilirubin levels are within the normal range, even with liver metastases.I am a woman who can still have children and have not been through menopause for 24 months.I haven't taken any experimental drugs recently.Your platelet count should be at least 100,000 per cubic millimeter.Your white blood cell count is at least 1,500 per cubic millimeter.I have been diagnosed with HIV.I am allergic to components in Nal-IRI, liposomal products, fluoropyrimidines, or leucovorin.I have a known DPD deficiency.You have a detectable tumor according to specific guidelines.My kidney function, measured by creatinine levels or clearance, is within the required range.My cancer will be or has been genetically tested before I start treatment.My cancer is a high-grade neuroendocrine tumor confirmed by tests.I am able to get out of my bed or chair and move around.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (liposomal irinotecan, leucovorin, fluorouracil)
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 currently signed up to participate in this research?
"Indeed, the listing on clinicaltrials.gov reveals that this trial is currently looking for 37 individuals at 2 sites. The trial was originally posted on 6/17/2019 and has since been updated 9/16/2022."
Answered by AI
Are there any life-threatening dangers associated with Liposomal Irinotecan?
"There is some data supporting Liposomal Irinotecan's safety, but none yet for efficacy. This received a score of 2."
Answered by AI
What is the standard purpose of Liposomal Irinotecan?
"Liposomal Irinotecan is most frequently used to treat rectal carcinoma, but it has also shown efficacy in the treatment of colorectal carcinoma, ovarian cancer, and sarcoma."
Answered by AI
Are there precedent studies which have used Liposomal Irinotecan?
"532 studies concerning Liposomal Irinotecan are currently underway, 148 of which are in Phase 3. Though most research is conducted in Shanghai, China, there are 25,565 total locations running these trials worldwide."
Answered by AI
Are there any current openings for this clinical trial?
"That is correct, the public information available on clinicaltrials.gov says that this study is still actively looking for participants. This trial was posted on June 17th, 2019 and updated September 16th, 2020. Currently, they are accepting 37 patients at 2 locations."
Answered by AI
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