Clinical trial NCT02550327: Gemcitabine, Nab-Paclitaxel, Cisplatin and Anakinra Treatment on Patients With Pancreatic Cancer
Official title: A Pilot Study of Gemcitabine, Nab-Paclitaxel, Cisplatin and Anakinra Treatment on Patients With Resectable or Potentially Resectable Pancreatic Adenocarcinoma (PDAC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pancreatic Adenocarcinoma
Keywords: resectable
potentially resectable
Pancreatic adenocarcinoma
PDAC
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria: A patient will be eligible for inclusion in this study if he or she meets all of the following criteria:

1. Male or female ≥ 18 years of age.
2. 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.
3. American Joint Committee on Cancer (AJCC) Stage I-III Pancreatic carcinoma.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
5. Serum albumin ≥2.0 gm/dL.
6. Expected survival ≥6 months.
7. 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).
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.

Exclusion Criteria: A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:

1. \< 18 years of age.
2. History of organ transplant.
3. 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.
4. Current, active immunosuppressive therapy such as cyclosporine, tacrolimus
5. Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias within the last 6 months.
6. Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever (temp \> 38°C).
7. 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.
8. Study consent form not signed.
9. Pregnant or nursing women.
10. Known HIV positive status.

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: 2 Years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Quality of Life
timeFrame: 2 years
measure: Toxicities and Adverse Events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
timeFrame: 2 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Charles A. Sammons Cancer Center
state: Texas
Study officials:
affiliation: Baylor Research Institute/Texas Oncology
name: Carlos Becerra, MD
role: PRINCIPAL_INVESTIGATOR
References: