Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)
NCT ID: NCT04926467
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
24 participants
INTERVENTIONAL
2021-07-23
2027-06-30
Brief Summary
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Detailed Description
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The study will enroll patients with pancreatic adenocarcinoma that are planned to receive pre-operative chemotherapy followed by surgical resection and post operative treatment. Local surgical/biopsy and pathology reports will constitute adequate documentation of histology/cytology for study inclusion.
Patients will receive pre- and post-operative chemotherapy plus Anakinra. Specifically, the pre-operative chemotherapy regimen will be a combination of Nab-paclitaxel, gemcitabine and cisplatin, while post-operative chemotherapy will use 5-Fluorouracil, oxaliplatin, and irinotecan. Patients will also receive growth factor (Neupogen followed by Neulasta) for safety and to ensure that treatment is not delayed due to neutropenic effects of chemotherapy.
Anakinra will be self-administered by the participants through out the treatment period. A treatment break of 2 days will be given prior to the surgery day.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Anakinra plus Chemotherapy
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.
Anakinra
Anakinra (100 mg) twice a day (BID), daily, will be self-administered subcutaneously starting on D1 of chemotherapy. Anakinra will be held 2 days prior to surgery. A dosing diary will be given to the patient for anakinra documentation.
Interventions
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Anakinra
Anakinra (100 mg) twice a day (BID), daily, will be self-administered subcutaneously starting on D1 of chemotherapy. Anakinra will be held 2 days prior to surgery. A dosing diary will be given to the patient for anakinra documentation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. 18 years of age or older
2. Histologically or Cytologically confirmed pancreatic ductal adenocarcinoma. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma.
3. Resectable, locally advanced or potentially resectable pancreatic adenocarcinoma
4. American Joint Committee on Cancer (AJCC) Stage I-III Pancreatic carcinoma.
5. Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 1
6. Serum albumin ≥2.0 g/dL.
7. Adequate hematologic function as defined by:
1. Absolute neutrophil count (ANC) ≥1500/mm3;
2. Platelets ≥70,000 x 10\^3/µl;
3. Hemoglobin ≥9 g/dL (in the absence of red blood transfusion).
8. Adequate liver function, as defined by:
1. Serum total bilirubin ≤2 x ULN mg/dL, prior to initiation of treatment.
2. ALT (SGPT) and AST (SGOT) ≤2.5 x upper limit of normal (ULN).
9. Adequate renal function, as defined by serum creatinine≤ 1.5 x ULN, or creatinine clearance ≥50 mL/min
10. Women of child bearing potential and men must agree to use contraception throughout the study and for one month after the last anakinra administration.
11. Subjects must understand and sign the informed consent form
12. Patients must be accessible for treatment and follow-up.
Exclusion Criteria
1. \<18 years of age
2. History of organ transplant.
3. Patients with islet cell neoplasms
4. Patients with stage IV pancreatic carcinoma
5. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
6. Known active infection with hepatitis B or hepatitis C
7. Presence of clinically significant cirrhosis as determined by the investigator
8. Known HIV positive status.
9. Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
10. Major surgery or vascular device placement within 2 weeks prior to Day 1 of treatment in study
11. Prior chemotherapy or radiation for pancreatic cancer
12. History of allergy or hypersensitivity to the study drugs
13. Patient is enrolled in any outside therapeutic clinical protocol or investigational trial with an investigational drug within 5 half-lives prior to Study ID assignment
14. Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor
15. Other malignancy within five years(except cutaneous, non-melanoma malignancies or cervical carcinoma in site), unless the probability of recurrence of the prior malignancy is \<5% as determined by the Principal Investigator based on available information.
16. Significant cardiac disease (uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias) within the last six months.
17. Other severe and/or uncontrolled medical conditions (e.g: prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation) or other conditions deemed by investigator as unsuitable for participation/enrollment
18. Peripheral sensory neuropathy \> or equal to grade 2 at baseline
19. Abnormal liver function tests as follows:
1. Total bilirubin of \> 2 x ULN
2. AST or ALT \> 5x ULN
20. Serum albumin ˂ 2.0 g/dL.
21. Abnormal hematologic function as follows :
1. Absolute neutrophil count (ANC) ˂ 1500/mm3;
2. Platelets ˂ 70,000 x 10\^3/µl;
3. Hemoglobin ˂ 9 g/dL (in the absence of red blood transfusion).
22. Pregnant or nursing women
23. No signed Informed consent form
18 Years
ALL
No
Sponsors
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Baylor Research Institute
OTHER
Responsible Party
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Principal Investigators
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A. Scott Paulson, MD
Role: PRINCIPAL_INVESTIGATOR
Charles A. Sammons Cancer Center/Texas Oncology
Locations
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Baylor University Medical Center, Charles A Sammons Cancer Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Solid Tumor Team
Role: primary
Other Identifiers
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020-476
Identifier Type: -
Identifier Source: org_study_id