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

NCT02550327 | Completed Early Phase 1 DMC

• 1 other identifier: 015-198
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Adenocarcinoma

Keywords

resectable; potentially resectable; Pancreatic adenocarcinoma; PDAC

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival (DFS)

  determine the number of patients who meet or surpass 11.5 months of disease free survival

  2 Years

Secondary Outcomes (3)

• Overall Survival (OS)

  2 years

• Quality of Life

  2 years

• Toxicities and Adverse Events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

  2 years

Study Arms (1)

All Patients

EXPERIMENTAL

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 complete a total of 6 cycles of chemotherapy.

Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Cisplatin; Drug: Anakinra

Interventions

Nab-paclitaxel DRUG

125 mg/m2

Also known as: Abraxane

All Patients

Gemcitabine DRUG

1000 mg/m2

Also known as: Gemzar ®

All Patients

Cisplatin DRUG

25 mg/m2

Also known as: Platinol

All Patients

Anakinra DRUG

100 mg

Also known as: Kineret

All Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age.
• Suspected PDAC prior to diagnosis or histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma. Subjects with suspected PDAC are those without a biopsy and a pancreas mass which appears to be metastatic disease. These subjects will be enrolled prior to biopsy and then excluded if a diagnosis of pancreas cancer is not confirmed by histology.
• American Joint Committee on Cancer (AJCC) Stage I-III Pancreatic carcinoma.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
• Serum albumin ≥2.0 gm/dL.
• Expected survival ≥6 months.
• Adequate hematologic function as defined by:
• Absolute neutrophil count (ANC) \>1500/mm3
• Platelets ≥70,000/mm3
• Hemoglobin \>9 g/dL (in the absence of red blood transfusion).
• 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).
• Adequate renal function, as defined by serum creatinine ≤ 1.5 x ULN, or creatinine clearance ≥50 mL/min
• 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.

You may not qualify if:

• \< 18 years of age.
• History of organ transplant.
• Other malignancy within five years, unless the probability of recurrence of the prior malignancy is \<5% as determined by the Principal Investigator based on available information.
• Current, active immunosuppressive therapy such as cyclosporine, tacrolimus
• Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias within the last 6 months.
• Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever (temp \> 38°C).
• Other severe and/or uncontrolled medical conditions or other conditions that in the opinion of the investigator could affect the participation of the patient on the study.
• Study consent form not signed.
• Pregnant or nursing women.
• Known HIV positive status.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; Cisplatin; Interleukin 1 Receptor Antagonist Protein

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Carlos Becerra, MD

  Baylor Research Institute/Texas Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 15, 2015
• Study Start: January 1, 2016
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: June 22, 2021

Record last verified: 2019-01

Locations

US (1)