Gemcitabine, Nab-Paclitaxel, Cisplatin and Anakinra Treatment on Patients With Pancreatic Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/30/2019 |
| Start Date: | January 2016 |
| End Date: | August 9, 2023 |
A Pilot Study of Gemcitabine, Nab-Paclitaxel, Cisplatin and Anakinra Treatment on Patients With Resectable or Potentially Resectable Pancreatic Adenocarcinoma (PDAC)
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.
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.
gemcitabine, cisplatin and anakinra.
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.
We found this trial at
1
site
Dallas, Texas 75246
Principal Investigator: Carlos Becerra, MD
Phone: 214-818-8472
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