What side effects are associated with this type of intervention?

Common treatments for Pancreatic Adenocarcinoma, such as FOLFIRINOX and gemcitabine/abraxane/cisplatin, are associated with a range of side effects. FOLFIRINOX can cause severe fatigue, neutropenia, diarrhea, and peripheral neuropathy. Gemcitabine combined with abraxane and cisplatin often leads to myelosuppression, neuropathy, and gastrointestinal symptoms like nausea and vomiting. Anakinra, an IL-1 inhibitor, may add risks of injection site reactions, infections, and neutropenia. Combining these treatments may increase the likelihood and severity of these side effects.

What prior FDA approvals exist?

FDA-approved treatments for Pancreatic Adenocarcinoma (PDAC) include chemotherapeutic agents like gemcitabine, nab-paclitaxel, and FOLFIRINOX. While Anakinra, an IL-1 inhibitor, is being studied for its role in inflammation modulation in PDAC, there are no specific FDA-approved IL-1 inhibitors for PDAC treatment as of now. Other treatments targeting cytokine signaling, such as etanercept (a TNF-α blocker), have been explored in combination with gemcitabine in clinical trials for advanced pancreatic cancer.

What other types of research exist?

Promising novel alternatives to Anakinra for Pancreatic Adenocarcinoma patients include: 1) Lenvatinib, a multikinase inhibitor, which has shown strong responses in advanced gastrointestinal neuroendocrine tumors and may have potential in PDAC. 2) Canakinumab, an anti-interleukin-1β monoclonal antibody, although initial trials did not meet primary endpoints, it is still being explored for its anticancer efficacy. 3) Immune checkpoint inhibitors like pembrolizumab, which have shown efficacy in other cancers and are being evaluated for PDAC. Patients should discuss these options with their oncologist to determine the best course of action.

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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

Must not have

Major surgery or vascular device placement within 2 weeks prior to Day 1 of treatment in study

Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test if adding Anakinra, an anti-inflammatory medication, to chemotherapy can improve treatment 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.

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.

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 below

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My kidney function is within the normal range.

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My pancreatic cancer can potentially be removed with surgery.

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My liver tests are within the normal range.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My pancreatic cancer is at an early to mid-stage (Stage I-III).

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My cancer is primarily pancreatic ductal adenocarcinoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery or any vascular device placement in the last 2 weeks.

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I do not have any ongoing serious infections requiring treatment.

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I am HIV positive.

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I have an active hepatitis B or C infection.

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I am currently on medication that suppresses my immune system.

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I have a tumor in the cells that make insulin in my pancreas.

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I have had an organ transplant.

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I am under 18 years old.

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My pancreatic cancer is at stage IV.

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I have not had serious heart issues like heart failure or heart attack in the last 6 months.

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I am allergic to the medication used in this study.

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I have moderate to severe numbness or tingling in my hands or feet.

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I have been treated with anakinra, canakinumab, or another IL-1 inhibitor.

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I have had chemotherapy or radiation for pancreatic cancer.

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My doctor has diagnosed me with serious liver cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132

19%

Acute Kidney Injury

11%

Ascites

Nausea

Urinary tract infection

Hematemesis

Upper GI hemorrhage

Clostridium difficile infection

Hepatic failure

Encephalopathy

C. difficile infection

Respiratory Failure

Peritonitis

Esophageal varices hemorrhage

Tachycardia

Multiple Organ Dysfunction Syndrome (MODS)

Viremia

Baceteremia

100%

80%

60%

40%

20%

Study treatment Arm

Anakinra & Pentoxifylline & Zinc Sulfate

Methylprednisolone

Observational

Awards & Highlights

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.

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

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pancreatic Adenocarcinoma (PDAC) include chemotherapy regimens such as FOLFIRINOX and gemcitabine combined with nab-paclitaxel. FOLFIRINOX works by combining multiple chemotherapeutic agents to inhibit cancer cell division and promote cell death, while gemcitabine interferes with DNA replication in cancer cells. Nab-paclitaxel enhances the delivery of chemotherapy to the tumor. Inflammation plays a central role in PDAC progression, with IL-1 being a key driver. Anakinra, an IL-1 inhibitor, is being studied for its potential to reduce inflammation and improve outcomes when combined with chemotherapy. This matters for PDAC patients as targeting inflammation alongside traditional chemotherapy may enhance treatment efficacy and potentially improve survival rates.

Differential role of Interleukin-1 and Interleukin-6 in K-Ras-driven pancreatic carcinoma undergoing mesenchymal transition.