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Fluoropyrimidine

Liposomal Irinotecan + FOLFOX for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Thomas George, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function: Hematologic- ANC > 1,500 cells/μl, Platelet count > 100,000 cells/μl, Hemoglobin > 9 g/dL, Hepatic- Serum total bilirubin within 1.5 x upper limit of normal, AST and ALT less than or equal to 2.5 x ULN, Renal- Serum creatinine less than or equal to 1.5 x ULN, Cardiac- Normal ECG or ECG without any clinically significant findings
Any biliary obstruction must have been treated
Must not have
Locally advanced unresectable disease or evidence of metastatic disease
A medical history of prior anti-cancer treatment for pancreatic cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment consisting of two drugs given together. The study will see if it is safe and works well in patients with pancreatic cancer.

Who is the study for?
Adults with a new diagnosis of resectable or borderline resectable, untreated pancreatic adenocarcinoma. Participants must have good performance status, treated biliary obstruction if present, no metastatic disease, and adequate organ function. Women and men must use effective contraception.
What is being tested?
The trial is testing the combination of Liposomal Irinotecan with FOLFOX (a chemo regimen) as a preoperative treatment for pancreatic cancer. It's an open-label study where all participants receive the same treatment to assess safety and feasibility.
What are the potential side effects?
Possible side effects include gastrointestinal symptoms like diarrhea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver enzyme alterations suggesting liver stress, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My bile duct blockage has been treated.
Select...
I have a new diagnosis of a type of pancreatic cancer that can possibly be removed by surgery.
Select...
My scans show that my disease might be removable with surgery.
Select...
I am fully active or can carry out light work.
Select...
My cancer has not spread to other parts of my body.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer cannot be surgically removed or has spread to other parts of my body.
Select...
I have received treatment for pancreatic cancer before.
Select...
I have not had any other cancer besides this one in the last 3 years.
Select...
I am taking strong medication that affects liver enzymes and cannot stop before joining the study.
Select...
I do not have ongoing diarrhea, infections, lung disease, or conditions that make the therapy unsafe for me.
Select...
I am not pregnant or breastfeeding.
Select...
I cannot have surgery for my condition.
Select...
I have a known DPD deficiency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Subjects Who Had Post-operative Complications 30 Days Post-surgery
Secondary study objectives
Difference Between Baseline and Maximal Nadir of Serum CA19-9 Level
Percentage of Patients Achieving a Best Overall Response of Partial or Complete Response (Objective Response Rate)
Percentage of Subjects Who Achieved a Complete Surgical Resection (R0)
+2 more

Side effects data

From 2013 Phase 3 trial • 1183 Patients • NCT00364013
60%
Diarrhoea
54%
Neutropenia
52%
Rash
45%
Nausea
34%
Fatigue
34%
Anorexia
32%
Dermatitis acneiform
31%
Paraesthesia
30%
Vomiting
30%
Hypomagnesaemia
29%
Pyrexia
27%
Abdominal pain
26%
Constipation
24%
Mucosal inflammation
24%
Stomatitis
23%
Asthenia
22%
Pruritus
21%
Paronychia
21%
Dry skin
20%
Thrombocytopenia
20%
Hypokalaemia
19%
Neuropathy peripheral
18%
Conjunctivitis
17%
Weight decreased
16%
Erythema
15%
Skin fissures
14%
Anaemia
14%
Epistaxis
14%
Alopecia
14%
Insomnia
13%
Dysgeusia
13%
Peripheral sensory neuropathy
13%
Acne
11%
Back pain
11%
Dyspepsia
10%
Oedema peripheral
9%
Dyspnoea
9%
Palmar-plantar erythrodysaesthesia syndrome
9%
Cough
8%
Leukopenia
8%
Abdominal pain upper
8%
Pain in extremity
8%
Anxiety
8%
Nail disorder
6%
Urinary tract infection
6%
Dizziness
6%
Dysaesthesia
6%
Headache
6%
Depression
5%
Dehydration
5%
Hypocalcaemia
5%
Dry mouth
5%
Nasopharyngitis
4%
Lacrimation increased
4%
Lethargy
4%
Hypertension
3%
Febrile neutropenia
3%
Intestinal obstruction
2%
Sepsis
2%
Colorectal cancer metastatic
2%
Pulmonary embolism
2%
Deep vein thrombosis
2%
Pneumonia
1%
Catheter related infection
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Intestinal perforation
1%
Small intestinal obstruction
1%
Chest pain
1%
General physical health deterioration
1%
Hepatic failure
1%
Cerebrovascular accident
1%
Renal failure acute
1%
Confusional state
1%
Renal failure
1%
Hypotension
1%
Ileus
1%
Hypersensitivity
1%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Panitumumab Plus FOLFOX
FOLFOX Alone

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: Liposomal irinotecan with FOLFOXExperimental Treatment2 Interventions
Subjects will receive 8 cycles and each cycle is 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFOX regimen
2009
Completed Phase 3
~2440
Liposomal Irinotecan
2019
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,399 Previous Clinical Trials
767,034 Total Patients Enrolled
IpsenIndustry Sponsor
350 Previous Clinical Trials
74,280 Total Patients Enrolled
Thomas George, MDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

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Pancreatic Adenocarcinoma Research Study Groups: Liposomal irinotecan with FOLFOX
Pancreatic Adenocarcinoma Clinical Trial 2023: 5-FU Highlights & Side Effects. Trial Name: NCT03483038 — Phase 2
5-FU (Fluoropyrimidine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03483038 — Phase 2
~7 spots leftby Nov 2025
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