Chemotherapy + Anakinra for Pancreatic Cancer

Overseen By Heather Williams, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Baylor Research Institute

Must not be taking: Immunosuppressants, IL-1 inhibitors

Disqualifiers: Organ transplant, Stage IV cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will test if adding Anakinra, an anti-inflammatory medication, to chemotherapy can improve treatment for patients with pancreatic cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on active immunosuppressive therapy or have had prior chemotherapy or radiation for pancreatic cancer.

How is the drug combination of Chemotherapy + Anakinra unique for treating pancreatic cancer?

The combination of chemotherapy with Anakinra, an anti-inflammatory drug typically used for conditions like rheumatoid arthritis, is unique for pancreatic cancer as it aims to reduce inflammation and potentially improve the effectiveness of chemotherapy. This approach is different from standard chemotherapy regimens, which do not typically include an anti-inflammatory component. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Anakinra, Kineret, Perioperative Chemotherapy for pancreatic cancer?

Research shows that using chemotherapy before and after surgery (perioperative chemotherapy) can improve survival rates in pancreatic cancer patients. Studies have demonstrated that combining different chemotherapy drugs before surgery can lead to better outcomes compared to surgery alone. ^{3 4 6 7 8}

Who Is on the Research Team?

Carlos Becerra, MD

Principal Investigator

Charles A. Sammons Cancer Center/Texas Oncology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients must be accessible for treatment and follow-up

My kidney function is within the normal range.

My pancreatic cancer can potentially be removed with surgery.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Chemotherapy

Participants receive pre-operative chemotherapy with Nab-paclitaxel, gemcitabine, and cisplatin, along with Anakinra

8-12 weeks

Surgery

Participants undergo surgical resection of pancreatic adenocarcinoma

1 week

Post-operative Chemotherapy

Participants receive post-operative chemotherapy with 5-fluorouracil, oxaliplatin, and irinotecan, along with Anakinra

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anakinra
• Perioperative Chemotherapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Anakinra plus Chemotherapy Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Published Research Related to This Trial

The NEONAX trial is a large, phase II study involving 166 patients with resectable pancreatic ductal adenocarcinoma, comparing the efficacy of perioperative chemotherapy (nab-paclitaxel and gemcitabine) against standard adjuvant therapy to improve disease-free survival (DFS) at 18 months.

Preliminary evidence suggests that nab-paclitaxel/gemcitabine has a favorable toxicity profile compared to FOLFIRINOX, making it a promising option for patients undergoing surgery for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group. Ettrich, TJ., Berger, AW., Perkhofer, L., et al.[2022]

Neoadjuvant chemotherapy, given before surgery, is safe and effective for patients with resectable pancreatic cancer, potentially improving their nutritional status and leading to a median survival of 26.5 months, as shown in a recent phase II trial.

The NEOPAC phase III trial will compare the efficacy of neoadjuvant chemotherapy followed by surgery against surgery followed by adjuvant chemotherapy, with a primary focus on progression-free survival in 310 patients, aiming to provide valuable insights into treatment outcomes for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study). Heinrich, S., Pestalozzi, B., Lesurtel, M., et al.[2022]

Adding adjuvant chemotherapy to surgery for localized pancreatic adenocarcinoma may improve overall survival rates, as suggested by the ESPAC-1 trial, despite the chemotherapy regimens being considered less effective for advanced disease.

The role of radiotherapy in combination with chemotherapy remains unclear, but it is still being explored as part of a comprehensive treatment strategy for localized pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined-modality treatment for operable pancreatic adenocarcinoma. Pisters, PW., Wolff, RA., Crane, CH., et al.[2007]

Chemotherapy regimens using gemcitabine or 5-FU have been shown to provide benefits for patients with advanced pancreatic carcinoma.

Adjuvant chemotherapy after complete surgical removal of the tumor may improve survival rates, as indicated by some studies, highlighting the potential for enhanced treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chemotherapy of pancreatic carcinoma]. Lutz, MP.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Perioperative Chemotherapy for Resectable Pancreatic Adenocarcinoma: A Phase 2 Randomized Clinical Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Adjuvant gemcitabine versus NEOadjuvant gemcitabine/oxaliplatin plus adjuvant gemcitabine in resectable pancreatic cancer: a randomized multicenter phase III study (NEOPAC study). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Combined-modality treatment for operable pancreatic adenocarcinoma. [2007]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Concepts and Outcomes of Perioperative Therapy in Stage IA-III Pancreatic Cancer-A Cross-Validation of the National Cancer Database (NCDB) and the German Cancer Registry Group of the Society of German Tumor Centers (GCRG/ADT). [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Systemic Chemotherapy as First-line Treatment for Metastatic Pancreatic Adenocarcinoma: A Bayesian Analysis. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Chemotherapy of pancreatic carcinoma]. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in metastatic pancreatic adenocarcinoma (PACT-19): a randomised phase 2 trial. [2022]