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Anti-metabolites

FOLFIRINOX for Pancreatic Cancer

Phase 2
Recruiting
Led By Ashwin Somasundaram, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has received no prior chemotherapy or chemoradiotherapy for pancreatic cancer. Subjects have not previously received surgery to remove pancreatic cancer
Age ≥ 18 years of age
Must not have
Subject has hypersensitivity to 5FU, oxaliplatin or other platinum agent, or irinotecan or to their excipients
Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial will enroll patients with resectable or borderline resectable PDAC who will receive FOLFIRINOX as neoadjuvant therapy (chemotherapy given before surgery).

Who is the study for?
This trial is for adults over 18 with a specific type of pancreatic cancer (adenocarcinoma) that hasn't spread or been treated yet. They must be able to have biopsies, potentially undergo surgery, and have no major health issues that would prevent surgery. Participants need good organ function and an expected lifespan of at least 6 months. Women who can bear children must test negative for pregnancy and use birth control.Check my eligibility
What is being tested?
The study tests if the FOLFIRINOX chemotherapy regimen—combining oxaliplatin, leucovorin, irinotecan hydrochloride, and 5-FU—can make pancreatic tumors easier to remove surgically by changing their genetic profile. It involves pre- and post-treatment biopsies to see how the tumor's DNA changes after eight treatments.See study design
What are the potential side effects?
FOLFIRINOX treatment may cause side effects like nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling in hands/feet (neuropathy), fatigue, hair loss, mouth sores.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had chemotherapy, chemoradiotherapy, or surgery for pancreatic cancer.
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I am 18 years old or older.
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My pancreatic cancer is confirmed and has not spread to distant parts of my body.
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I can carry out all my usual activities without help.
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I agree to have biopsies of my pancreatic mass before and after treatment.
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My pancreatic cancer is advanced but hasn't been removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to certain chemotherapy drugs like 5FU, oxaliplatin, or irinotecan.
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I have not had major surgery or a significant injury in the last 4 weeks.
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I have a known DPD enzyme deficiency.
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I experience significant numbness or pain in my hands or feet.
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My pancreatic cancer has returned or spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best disease control rate by Pancreatic ductal adenocarcinoma (PDAC) subtype
Secondary outcome measures
Overall survival
Progression free survival
R0 resection rate
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: SingleArm: FOLFIRINOXExperimental Treatment4 Interventions
Subjects will receive FOLFIRINOX as an outpatient every 14 days per community standards of medical care. Protocol-based therapy will continue for 12 cycles (24 weeks) or until disease progression, unacceptable toxicity, study withdrawal, or subject death. Subjects will have the option of surgical resection after 8 cycles of therapy if repeat scans show evidence of resectable disease. The starting doses for mFOLFIRINOX regimen are: oxaliplatin 85 mg/m2, followed by leucovorin 400 mg/m2 given simultaneously with irinotecan 180mg/m2, followed by 5FU 400 mg/m2 bolus and then 2400 mg/m2 via continuous infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin
2005
Completed Phase 4
~5730
5-FU
2014
Completed Phase 3
~3420
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
354 Previous Clinical Trials
91,413 Total Patients Enrolled
Ashwin Somasundaram, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
3 Previous Clinical Trials
75 Total Patients Enrolled
Autumn McRee, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
8 Previous Clinical Trials
333 Total Patients Enrolled

Media Library

5-FU (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03977233 — Phase 2
Pancreatic Adenocarcinoma Research Study Groups: SingleArm: FOLFIRINOX
Pancreatic Adenocarcinoma Clinical Trial 2023: 5-FU Highlights & Side Effects. Trial Name: NCT03977233 — Phase 2
5-FU (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03977233 — Phase 2
~16 spots leftby Jul 2027
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