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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

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

Primary study objectives

Best disease control rate by Pancreatic ductal adenocarcinoma (PDAC) subtype

Secondary study objectives

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

~2890

Leucovorin

2005

Completed Phase 4

~6010