Active — Not RecruitingPhase 2

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

United States45 participantsStarted 2018-12-13

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. ANC \> 1,500 cells/μl without the use of hematopoietic growth factors; and
✓. Platelet count \> 100,000 cells/μl; and
✓. Hemoglobin \> 9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL)
✓. 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),
✓. AST and ALT less than or equal to 2.5 x ULN

What they're measuring

Percentage of Subjects Who Had Post-operative Complications 30 Days Post-surgery

Timeframe: 30 days

Trial details

NCT IDNCT03483038

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-16

Results submitted2024-08-19

View on ClinicalTrials.gov More Pancreatic Adenocarcinoma trials