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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.

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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My cancer is a high-grade neuroendocrine tumor confirmed by tests.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious illnesses that would stop me from following the study's requirements.

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I haven't taken any experimental drugs recently.

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I have been diagnosed with HIV.

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I am allergic to components in Nal-IRI, liposomal products, fluoropyrimidines, or leucovorin.

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I have a known DPD deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Secondary study objectives

Clinical Benefit Response

Incidence of Grade 3+ Treatment Related Adverse Events (TRAE)

Overall Survival

+4 more

Other study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~11700

Leucovorin

2005

Completed Phase 4

~6010