Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)
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|ClinicalTrials.gov Identifier: NCT04926467|
Recruitment Status : Not yet recruiting
First Posted : June 15, 2021
Last Update Posted : June 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: Anakinra||Phase 2|
This is an open-label, single-arm, prospective phase II study conducted by Baylor Scott and White Research Institute in Dallas.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Phase II Study of Chemotherapy + Anakinra in Patients With Resectable, Locally Advanced or Potentially Resectable Pancreatic Adenocarcinoma (PDAC)|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||June 2025|
|Estimated Study Completion Date :||June 2026|
Experimental: 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.
Pre-operative treatment: Nab-paclitaxel (125 mg/m2), gemcitabine (1000 mg/m2), and cisplatin (25 mg/m2) will be given on Day 1 and 8 of a 21-day cycle. Patients will receive anakinra 100 mg injection twice a day starting on day 1 of chemotherapy. Anakinra will be self-administered by the patients and will be discontinued 2 days prior to surgery. Total number of cycles = 4.
Post-operative treatment: 5-Fluorouracil (2400 mg/m2 CI for 48 hours), oxaliplatin (85 mg/m2), and irinotecan (150 mg/m2) will be given once every 2 weeks (1 cycle =14 days). Patients will receive anakinra 100 mg injection subcutaneously twice a day starting on day 1 of chemotherapy (initiated within 4-8 weeks after surgery). Anakinra will be self-administered by the patient throughout the treatment without any break. Total number of cycles = 8.
- 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. [ Time Frame: 24 months ]
- 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. [ Time Frame: 24 months ]
- To determine the effect of anakinra in combination with perioperative chemotherapy on the median disease free survival (DFS). A benchmark of 12 months DFS will be used to determine how many patients meet or exceed this goal. [ Time Frame: 12 months ]
- To determine the effect of anakinra in combination with perioperative chemotherapy on response rate [ Time Frame: 24 months ]
- To determine the R0 resection rates (complete tumor removal with negative resection margins) obtained with anakinra + pre-operative chemotherapy. [ Time Frame: 24 months ]
- To describe the effect of anakinra in combination with perioperative chemotherapy on the prevalence and severity of pain by monitoring patients' pain level using memorial pain assessment card (MPAC). [ Time Frame: 24 months ]
- To determine the effect of anakinra in combination with perioperative chemotherapy on patients' health-related quality of life by monitoring patients using EORTC quality of life survey questionnaire (EORTC QLQ-C30). [ Time Frame: 24 months ]
- To determine the effect of anakinra in combination with perioperative chemotherapy on the inflammasomes ( IL6, CRP, IL1α and IL1β) in blood and in the resected pathology specimens. [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04926467
|Contact: Heather Williams, MS||(214) 818-7879||Heather.Williams1@BSWHealth.org|
|Contact: Joyce Ghormley||(214) 818-8961||Joyce.Ghormley@BSWHealth.org|
|United States, Texas|
|Baylor University Medical Center, Charles A Sammons Cancer Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Carlos Becerra, MD||Charles A. Sammons Cancer Center/Texas Oncology|