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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My bile duct blockage has been treated.
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I have a new diagnosis of a type of pancreatic cancer that can possibly be removed by surgery.
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My scans show that my disease might be removable with surgery.
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I am fully active or can carry out light work.
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My cancer has not spread to other parts of my body.
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I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
30 day post operative complication rate
Secondary outcome measures
Biochemical Response Rate
Objective Response Rate
Patient-Reported Quality of Life
+4 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%
Dry skin
21%
Paronychia
20%
Thrombocytopenia
20%
Hypokalaemia
19%
Neuropathy peripheral
18%
Conjunctivitis
17%
Weight decreased
16%
Erythema
15%
Skin fissures
14%
Alopecia
14%
Anaemia
14%
Epistaxis
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%
Abdominal pain upper
8%
Nail disorder
8%
Leukopenia
8%
Pain in extremity
8%
Anxiety
6%
Dysaesthesia
6%
Dizziness
6%
Headache
6%
Urinary tract infection
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%
Chest pain
1%
Gastrointestinal haemorrhage
1%
Intestinal perforation
1%
Cerebrovascular accident
1%
Confusional state
1%
Renal failure acute
1%
Atrial fibrillation
1%
Small intestinal obstruction
1%
General physical health deterioration
1%
Catheter related infection
1%
Hepatic failure
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

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
1,340 Previous Clinical Trials
715,660 Total Patients Enrolled
IpsenIndustry Sponsor
345 Previous Clinical Trials
73,183 Total Patients Enrolled
Thomas George, MDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

5-FU (Fluoropyrimidine) Clinical Trial Eligibility Overview. Trial Name: NCT03483038 — Phase 2
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

Frequently Asked Questions

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

How many health care facilities are engaged in this experiment?

"At present, 4 sites are running this experiment. Tallahassee, Indianapolis and Gainesville all have a clinical trial centre with additional locations spread throughout the area. To reduce travel needs in case of enrollment, it is recommended to choose the closest site."

Answered by AI

Does this research require participants to be 35 or younger?

"This trial's stipulations require that all participants must be between 18 and 99 years old. Those younger than 18 have 49 different trials open to them, while those older than 65 can choose from 1,019 opportunities."

Answered by AI

Who is eligible to participate in this medical experiment?

"This medical trial is currently seeking 53 individuals aged 18-99 that are diagnosed with adenocarcinoma. In addition to meeting this age criteria, patients must also have a new clinical diagnosis of resectable or borderline resectable pancreatic adenocarcinoma confirmed by pathology exam results; they cannot have any signs of metastatic disease and their ECOG performance rating needs to be 0 or 1. Moreover, it's essential that the subject has an ANC exceeding 1,500 cells/μl without needing hematopoietic growth factors and platelet count higher than 100,000 cells/ μl. Lastly"

Answered by AI

Has the FOLFOX combination been accorded official approval by the FDA?

"There exists some evidence of FOLFOX regimen's safety, but none on its efficacy. Thus, our team at Power rate this treatment with a score of 2."

Answered by AI

To what extent is enrollment for this clinical trial increasing?

"Affirmative. Clinicaltrials.gov discloses that the trial is currently accepting applicants, launching on December 13th 2018 and last edited November 17th 2022. 53 participants are sought from 4 sites for this study."

Answered by AI

In what cases is the FOLFOX regimen typically prescribed?

"FOLFOX regimens are well-known for their efficacy at treating malignant neoplasm of the pancreas. Other afflictions it may help manage include metastatic tumors, stomach cancer, and rhabdomyosarcoma."

Answered by AI

Have any other experimental studies utilized the FOLFOX regimen?

"Initially developed in 2002 at Mayo Clinic, Rochester, the FOLFOX regimen has been utilized for 520 studies to date. Currently, 263 trials are actively enrolling participants with a focus on Tallahassee and Indiana."

Answered by AI

Are there any current openings available to participants in this investigation?

"Affirmative. Supporting evidence hosted on clinicaltrials.gov shows that recruitment for this medical trial began in December 13th 2018 and is ongoing as of November 17th 2022, with a need to enlist 53 participants from four separate locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma
2018. "A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03483038.
~7 spots leftby Apr 2025
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