Clinical Trials /

A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

NCT03483038

Description:

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable pancreatic cancer. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of the Safety and Activity of Nal-IRI
  • Official Title: A Phase II, Open-label Pilot Study Evaluating the Safety and Activity of Nal-IRI in Combination With 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma (NEO-Nal- IRI Study)

Clinical Trial IDs

  • ORG STUDY ID: UF-STO-PANC-004
  • SECONDARY ID: UF-STO-PANC-004
  • NCT ID: NCT03483038

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DrugSynonymsArms
Liposomal IrinotecanONIVYDELiposomal irinotecan with FOLFOX
FOLFOX regimenLiposomal irinotecan with FOLFOX

Purpose

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable pancreatic cancer. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Trial Arms

NameTypeDescriptionInterventions
Liposomal irinotecan with FOLFOXExperimentalSubjects will receive 8 cycles and each cycle is 14 days.
  • Liposomal Irinotecan
  • FOLFOX regimen

Eligibility Criteria

        Inclusion Criteria:

          -  Must be at least 18 years of age.

          -  A new clinical diagnosis of resectable or borderline resectable, previously untreated
             pancreatic adenocarcinoma confirmed by pathologic specimen

          -  No clinical evidence of metastatic disease

          -  Potentially resectable disease, as confirmed by CT or MRI of the abdomen

          -  ECOG performance status of 0 or 1

          -  Any biliary obstruction must have been treated.

          -  Subjects with known or suspected Gilbert's disease must be formally tested for
             UGT1A1*28 with results available to study team prior to treatment initiation

          -  Adequate organ function; as defined by:

             i. Hematologic-

               1. ANC > 1,500 cells/μl without the use of hematopoietic growth factors; and

               2. Platelet count > 100,000 cells/μl; and

               3. Hemoglobin > 9 g/dL (blood transfusions are permitted for patients with
                  hemoglobin levels below 9 g/dL)

        ii. Hepatic-

          1. Serum total bilirubin within normal range for the institution (biliary drainage is
             allowed for biliary obstruction),

          2. AST and ALT less than or equal to 2.5 x ULN

        iii. Renal- a. Serum creatinine less than or equal to 1.5 x ULN

        iv. Cardiac-

        a. Normal ECG or ECG without any clinically significant findings as defined by the treating
        physician

          -  Women of childbearing potential must be using an adequate method of contraception to
             avoid pregnancy throughout the study and for at least 6 weeks after the last dose of
             study drug to minimize the risk of pregnancy

          -  Males with female partners of child-bearing potential must agree to use
             physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy)
             throughout the study and should avoid conceiving children for 6 weeks following the
             last dose of study drug.

        Exclusion Criteria:

          -  A medical history of prior anti-cancer treatment for pancreatic cancer.

          -  Locally advanced unresectable disease or evidence of metastatic disease.

          -  Any other invasive malignancy within the past three years.

          -  Presence of any known contraindications to or hypersensitivities to the
             investigational products.

          -  Use of strong CYP3A4 inhibitors or inducers which cannot be discontinued prior to
             study entry.

          -  A non-surgical candidate.

          -  Subject is unable to understand, provide consent or comply with study requirements,
             treatments or instructions in the opinion of the treating physician.

          -  Uncontrolled diarrhea, active infection, known interstitial lung disease or other
             medical condition that precludes safe administration of this combination therapy
             consistent with manufacturer recommendations.

          -  Unwilling/unable to comply with birth control requirements while on study.

          -  Females or males of childbearing potential who are unwilling or unable to use an
             acceptable method to avoid pregnancy for the entire study period and for at least 6
             weeks after the last dose of study drug.

          -  Females who are pregnant or breastfeeding.

          -  History of any other disease, metabolic dysfunction, physical examination finding, or
             clinical laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates the use of protocol therapy or that might affect the interpretation of
             the results of the study or that puts the subject at high risk for treatment
             complications, in the opinion of the treating physician.

          -  Prisoners or subjects who are involuntarily incarcerated.

          -  Subjects who are compulsorily detained for treatment of either a psychiatric or
             physical illness.

          -  Subjects demonstrating an inability to comply with the study and/or follow-up
             procedures.

          -  Known dihydrypyrimidine (DPD) deficiency
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:30 day post operative complication rate
Time Frame:30 days
Safety Issue:
Description:To determine the 30 day post operative complication rate, as measured by hospital readmission, death, second surgery or interventional procedure, or major complications extending hospital stay

Secondary Outcome Measures

Measure:Treatment Completion Rate
Time Frame:4 months
Safety Issue:
Description:To determine the treatment completion rate of therapy, as defined by the percentage of subjects that completed all intended cycles
Measure:Rate of complete surgical resection
Time Frame:7 months
Safety Issue:
Description:To determine the rate of complete surgical resection (R0)
Measure:Objective Response Rate
Time Frame:5 months
Safety Issue:
Description:To determine radiographic objective response rate of the primary tumor as measured by RECIST v 1.1 criteria
Measure:Biochemical Response Rate
Time Frame:9 months
Safety Issue:
Description:To determine the biochemical response rate and pattern of response as measured by serial CA 19-9 levels
Measure:Patient-Reported Quality of Life
Time Frame:9 months
Safety Issue:
Description:To determine the patient-reported quality of life during treatment as measured by the NCI validated FACT-G survey
Measure:Rate of other pathologic downstaging
Time Frame:7 months
Safety Issue:
Description:To determine the rate of other pathologic downstaging
Measure:To determine the safety of liposomal irinotecan in combination with 5-fluorouracil, oxaliplatin, and leucovorin as assessed by the number of treatment-related adverse events as assessed by CTCAE v 4.0
Time Frame:9 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Florida

Trial Keywords

  • pancreatic adenocarcinoma
  • neoadjuvant
  • ONIVYDE
  • chemotherapy
  • borderline resectable

Last Updated

March 30, 2018