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Trial record 1 of 1 for:    NCT03483038
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03483038
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : June 7, 2022
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Drug: Liposomal Irinotecan Drug: FOLFOX regimen Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label Pilot Study Evaluating the Safety and Activity of Liposomal Irinotecan in Combination With 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma (NEO-Nal- IRI Study)
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Liposomal irinotecan with FOLFOX
Subjects will receive 8 cycles and each cycle is 14 days.
Drug: Liposomal Irinotecan
Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle.
Other Name: ONIVYDE

Drug: FOLFOX regimen
Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.

Primary Outcome Measures :
  1. 30 day post operative complication rate [ Time Frame: 30 days ]
    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 :
  1. Treatment Completion Rate [ Time Frame: 4 months ]
    To determine the treatment completion rate of therapy, as defined by the percentage of subjects that completed all intended cycles

  2. Rate of complete surgical resection [ Time Frame: 7 months ]
    To determine the rate of complete surgical resection (R0)

  3. Objective Response Rate [ Time Frame: 5 months ]
    To determine radiographic objective response rate of the primary tumor as measured by RECIST v 1.1 criteria

  4. Biochemical Response Rate [ Time Frame: 9 months ]
    To determine the biochemical response rate and pattern of response as measured by serial CA 19-9 levels

  5. Patient-Reported Quality of Life [ Time Frame: 9 months ]
    To determine the patient-reported quality of life during treatment as measured by the NCI validated FACT-G survey

  6. Rate of other pathologic downstaging [ Time Frame: 7 months ]
    To determine the rate of other pathologic downstaging

  7. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 evaluation
  • No clinical evidence of metastatic disease
  • Potentially resectable local 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 1.5 x upper limit of normal (ULN) for the institution, with a trend downwards (biliary drainage is allowed for biliary obstruction),
    2. AST and ALT less than or equal to 2.5 x ULN

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

      iv. Cardiac- 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 7 months 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 4 months 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 7 months for females and 4 months for males 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03483038

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Contact: Alexandra Mueller (352) 273-9785

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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Jack Bates    352-265-5121   
Principal Investigator: Thomas George, MD         
Orlando Health UF Health Cancer Center Recruiting
Orlando, Florida, United States, 32806
Contact: Andrea Thomas    321-841-8284   
Principal Investigator: Omar Kayaleh, MD         
Tallahassee Memorial Health Care Recruiting
Tallahassee, Florida, United States, 32308
Contact: Brittany Stith    850-431-0673   
Principal Investigator: Karen Russell, MD         
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lynne McCranor    317-278-4712   
Principal Investigator: Anita Turk, MD         
Sponsors and Collaborators
University of Florida
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Principal Investigator: Thomas George, MD University of Florida
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Responsible Party: University of Florida Identifier: NCT03483038    
Other Study ID Numbers: UF-STO-PANC-004
IRB201800866 -A ( Other Identifier: University of Florida )
OCR16281 ( Other Identifier: UF OnCore )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Florida:
pancreatic adenocarcinoma
borderline resectable
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents