An Open Label, Phase II Study of Chemotherapy + Anakinra in Patients With Resectable, Locally Advanced or Potentially Resectable Pancreatic Adenocarcinoma (PDAC)
Baylor Research Institute
Summary
Based on a central role of inflammation in pancreas cancer, the role of IL 1 in acute and chronic inflammation , the inhibitory effect of IL 1 alfa and beta by anakinra and preliminary experience with anakinra in combination with chemotherapy in metastasis (with FOLFIRINOX) and localized disease (with gemcitabine/abraxane/cisplatin), a phase 2 study with anakinra in combination with perioperative chemotherapy for patients with PDAC is being proposed.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * A patient will be eligible for inclusion in this study if he or she meets all of the following 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…
Interventions
- DrugAnakinra
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.
Location
- Baylor University Medical Center, Charles A Sammons Cancer CenterDallas, Texas