Your session is about to expire
← Back to Search
Chemotherapy
Chemotherapy + Anakinra for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Carlos Becerra, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate renal function: serum creatinine≤ 1.5 x ULN, or creatinine clearance ≥50 mL/min
Resectable, locally advanced or potentially resectable pancreatic adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will test whether the addition of the drug anakinra to standard chemotherapy can improve outcomes for patients with pancreatic cancer.
Who is the study for?
Adults with resectable or locally advanced pancreatic adenocarcinoma (stages I-III) can join. They must be in good health overall, with specific blood and organ function criteria met. Participants need to agree to use contraception during the study and for a month after, and they cannot have had prior treatments for their cancer.Check my eligibility
What is being tested?
The trial is testing Anakinra combined with chemotherapy in patients undergoing surgery for pancreatic cancer. It's based on how inflammation affects pancreas cancer and aims to see if blocking certain inflammatory signals can help improve treatment outcomes.See study design
What are the potential side effects?
Anakinra may cause reactions at the injection site, increased risk of infections due to immune system suppression, headaches, nausea, diarrhea, joint pain or swelling. The side effects from chemotherapy could include fatigue, hair loss, mouth sores and an increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the normal range.
Select...
My pancreatic cancer can potentially be removed with surgery.
Select...
My liver tests are within the normal range.
Select...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My pancreatic cancer is at an early to mid-stage (Stage I-III).
Select...
My cancer is primarily pancreatic ductal adenocarcinoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the percentage of patients that have a normalization of CA19-9 after pre-op treatment with the combination of nab-paclitaxel (abraxane), gemcitabine, cisplatin and anakinra.
Secondary outcome measures
Pharmacotherapy
To determine the R0 resection rates (complete tumor removal with negative resection margins) obtained with anakinra + pre-operative chemotherapy.
To determine the effect of anakinra in combination with perioperative chemotherapy on overall survival (OS) of PDAC patients. A benchmark of 24 months OS will be used to determine how many patients meet or exceed this goal.
+4 moreSide effects data
From 2018 Phase 2 & 3 trial • 104 Patients • NCT0180913219%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational
Trial Design
1Treatment groups
Experimental Treatment
Group I: Anakinra plus ChemotherapyExperimental Treatment1 Intervention
Patients will receive Anakinra during both pre-operative chemotherapy with Nab-paclitaxel, gemcitabine and cisplatin, followed by surgery and post-operative chemotherapy with 5-fluorouracil, oxaliplatin, and irinotecan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
FDA approved
Find a Location
Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
201 Previous Clinical Trials
203,256 Total Patients Enrolled
Carlos Becerra, MDPrincipal InvestigatorCharles A. Sammons Cancer Center/Texas Oncology
5 Previous Clinical Trials
69 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is within the normal range.I have not had major surgery or any vascular device placement in the last 2 weeks.I do not have any ongoing serious infections requiring treatment.I am HIV positive.I have an active hepatitis B or C infection.I am currently on medication that suppresses my immune system.I have a tumor in the cells that make insulin in my pancreas.I have had an organ transplant.My pancreatic cancer can potentially be removed with surgery.My liver tests are within the normal range.I am under 18 years old.My pancreatic cancer is at stage IV.I have not had serious heart issues like heart failure or heart attack in the last 6 months.I am allergic to the medication used in this study.I have moderate to severe numbness or tingling in my hands or feet.I have been treated with anakinra, canakinumab, or another IL-1 inhibitor.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.My pancreatic cancer is at an early to mid-stage (Stage I-III).My cancer is primarily pancreatic ductal adenocarcinoma.I have had chemotherapy or radiation for pancreatic cancer.My doctor has diagnosed me with serious liver cirrhosis.I haven't had cancer, except for skin or cervical cancer, in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Anakinra plus Chemotherapy
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger