Chemotherapy for Pancreatic Neuroendocrine Carcinoma

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Must not be taking: Steroids, Investigational therapy

Disqualifiers: CNS metastases, DPD deficiency, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Up to 3 years

11 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well liposomal irinotecan, leucovorin, and fluorouracil work in treating patients with high grade neuroendocrine cancer of gastrointestinal, unknown, or pancreatic origin that does not respond to treatment and has spread to other places in the body. Lliposomal irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving liposomal irinotecan, leucovorin and fluorouracil may work better in treating patients with neuroendocrine cancer.

Research Team

Renuka V. Iyer

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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.

Inclusion 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.

Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

Your hemoglobin level is at least 9 grams per deciliter.

Exclusion Criteria

Any condition which in the Investigator?s opinion deems the participant an unsuitable candidate to receive study drug.

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

I have stable brain metastases, not on steroids for 7 days, and no carcinomatous meningitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive liposomal irinotecan, leucovorin, and fluorouracil intravenously on days 1 and 15 of each 28-day cycle

Up to 3 years

Visits on days 1 and 15 of each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

30 days, then every 2 months

Treatment Details

Interventions

• Fluorouracil
• Leucovorin
• Liposomal Irinotecan

Trial Overview 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.

Participant Groups

Group I: Treatment (liposomal irinotecan, leucovorin, fluorouracil) Experimental Treatment 4 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.

Fluorouracil is already approved in United States, European Union, Canada for the following indications:

Approved in United States as 5-Fluorouracil for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer
• Skin cancer

Approved in European Union as 5-Fluorouracil for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer

Approved in Canada as 5-Fluorouracil for:

• Colorectal cancer
• Breast cancer
• Stomach cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Ipsen

Industry Sponsor

Trials

358

Recruited

74,600+

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD