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Anti-metabolites

FOLFIRINOX for Pancreatic Cancer

Phase 2
Recruiting
Led By Autumn McRee, 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
Histologically or cytologically confirmed adenocarcinoma of the pancreas with no evidence of distant metastatic disease
Female subjects of childbearing potential must have a negative serum or urine pregnancy test performed within 14 days prior to initiation of FOLFIRINOX
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Study 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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My pancreatic cancer is confirmed and has not spread to distant parts of my body.
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I am a woman who can have children and have had a negative pregnancy test in the last 14 days.
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I have not had chemotherapy, chemoradiotherapy, or surgery for pancreatic cancer.
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I agree to have biopsies of my pancreatic mass before and after treatment.
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I am 18 years old or older.
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I agree to use effective birth control during and for 8 weeks after the study.
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I am considered fit for surgery to remove pancreatic cancer by a surgeon.
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My pancreatic cancer is advanced but hasn't been removed by surgery.
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My organs are functioning well enough for me to join the study.
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I can carry out all my usual activities without help.

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

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: 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
344 Previous Clinical Trials
85,574 Total Patients Enrolled
Autumn McRee, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
8 Previous Clinical Trials
333 Total Patients Enrolled
Ashwin Somasundaram, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
3 Previous Clinical Trials
75 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the short-term side effects associated with taking Oxaliplatin?

"While there is some data suggesting that Oxaliplatin is safe, it did not receive a higher score because Phase 2 trials lack efficacy data."

Answered by AI

Can new patients still join this trial?

"That is accurate. The website clinicaltrials.gov has the most recent information on this trial, which was posted June 12th, 2019 and edited June 8th, 2020. This study is looking for 45 individuals at a single site."

Answered by AI

What are some other examples of research done with Oxaliplatin?

"There are a total of 676 studies investigating oxaliplatin. 207 of these studies are clinical trials that are currently ongoing. While the majority of these trials originated in Guangzhou, Guangdong, there are 28744 locations worldwide where patients can receive this treatment as part of a trial."

Answered by AI

What are the enrolment requirements for this medical study?

"This clinical trial is admitting 45 patients with cancer of the pancreas between the ages of 18 and 99. Most notable, applicants should meet the following criteria: have not received prior chemotherapy or chemoradiotherapy for pancreatic cancer, have not had surgery to remove pancreatic cancer, be in good physical health as determined by ECOG performance status 0 or 1., have no evidence of co-morbidities precluding the potential to undergo surgical resection of PDAC as determined by surgical investigator., and have measurable or non-measurable but evaluable (as determined by Response Evaluation Criteria in Solid Tumors version 1."

Answered by AI

How many individuals are being given this medication as part of the trial?

"The clinical trial is still admitting patients and was originally posted on 6/12/2019. The most recent update was on 6/8/2022. 45 participants are needed and 1 site is sufficient."

Answered by AI

For this particular experiment, are elders welcome to participate?

"The age range for participants in this trial is 18 to 99 years old."

Answered by AI

For what illnesses is Oxaliplatin most commonly prescribed?

"Oxaliplatin is most often used to treat rectal carcinoma, but it can also be effective in fighting other forms of cancer like colorectal carcinoma, ovarian cancer, and sarcoma."

Answered by AI
~19 spots leftby Jul 2027