Gemcitabine, Nab-Paclitaxel, Cisplatin And Anakinra Treatment On Patients With Pancreatic Cancer

Study Overview

Gemcitabine, Nab-Paclitaxel, Cisplatin and Anakinra Treatment on Patients With Pancreatic Cancer

The objective of this study is to improve survival by the addition of anakinra to the chemotherapy combination of nab-paclitaxel, gemcitabine, and cisplatin in patients with resectable or potentially resectable pancreatic adenocarcinoma (PDAC). The primary endpoint of the study is to determine whether the combination of abraxane, gemcitabine, cisplatin, and anakinra will improve disease-free survival (DFS) and to determine the number of patients who meet or surpass 11.5 months of DFS. The secondary objectives of this study are to evaluate the effect of anakinra when combined with the three-drug regimen of nab-paclitaxel, gemcitabine, and cisplatin on response rate and overall survival after diagnosis and adverse events of patients with resectable or potentially resectable PDAC. The investigators will use the benchmark of 24 months overall survival (OS) to determine how many patients meet or exceed this goal. The investigators will monitor, by survey, patients' health related quality of life while on treatment to determine if the addition of anakinra improves this measure.

This is a single-arm, open-label pilot study. Patients will receive Nab-paclitaxel, gemcitabine, cisplatin and anakinra.

Pancreatic Adenocarcinoma

DRUG: Nab-paclitaxel
DRUG: Gemcitabine
DRUG: Cisplatin
DRUG: Anakinra

015-198

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-09-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-06-21
First Submitted that Met QC Criteria 2015-09-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-06-22
First Posted (ACTUAL) 2015-09-15	Results First Posted N/A	Last Verified 2019-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: All Patients All patients will receive Nab-paclitaxel, Gemcitabine, Cisplatin, and Anakinra given on Day 1 and 8 of a 21 day cycle (two weeks on with one week rest). Anakinra will be self-administered subcutaneously corresponding with chemotherapy. The patient will c	DRUG: Nab-paclitaxel 125 mg/m2 DRUG: Gemcitabine 1000 mg/m2 DRUG: Cisplatin 25 mg/m2 DRUG: Anakinra 100 mg

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: All Patients

All patients will receive Nab-paclitaxel, Gemcitabine, Cisplatin, and Anakinra given on Day 1 and 8 of a 21 day cycle (two weeks on with one week rest). Anakinra will be self-administered subcutaneously corresponding with chemotherapy. The patient will c

DRUG: Nab-paclitaxel

125 mg/m2

DRUG: Gemcitabine

1000 mg/m2

DRUG: Cisplatin

25 mg/m2

DRUG: Anakinra

100 mg

Primary Outcome Measures	Measure Description	Time Frame
Disease Free Survival (DFS)	determine the number of patients who meet or surpass 11.5 months of disease free survival	2 Years

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival (OS)	The use of a benchmark of 24 months overall survival will be used to determine how many patients meet or exceed this goal.	2 years
Quality of Life	The use of surveys will capture the patients' health-related quality life while on treatment to determine if the addition of anakinra improves this measure.	2 years
Toxicities and Adverse Events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.	Toxicities and adverse events will be recorded from the of informed consent to 30 days following the last study treatment.	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Absolute neutrophil count (ANC) >1500/mm3
Platelets ≥70,000/mm3
Hemoglobin >9 g/dL (in the absence of red blood transfusion). 8. Adequate liver function, as defined by:

Serum total bilirubin ≤2 x ULN mg/dL, prior to initiation of treatment.
Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤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. All females of child bearing potential must agree to use contraception to avoid pregnancy throughout the study and for one month after the last dose. 11. Patients must be accessible for treatment and follow-up. 12. Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Patients may not be consented by a medical power of attorney.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Carlos Becerra, MD, Baylor Research Institute/Texas Oncology

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record