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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT03483038
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Irinotecan — DRUG
    Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle.
  • FOLFOX regimen — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 13, 2018
Status verified
Feb 2026
Primary completion
Sep 16, 2023
Completion
Dec 31, 2026

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal irinotecan with FOLFOX
    Subjects will receive 8 cycles and each cycle is 14 days.

Primary Outcome Measure

Percentage of Subjects Who Had Post-operative Complications 30 Days Post-surgery [ Time Frame: 30 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608-
Orlando Health UF Health Cancer CenterOrlandoFlorida32806-
Tallahassee Memorial Health CareTallahasseeFlorida32308-
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-

Find similar trials in Gainesville, FL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Florida· Gainesville, FLOrlando Health UF Health Cancer Center· Orlando, FLTallahassee Memorial Health Care· Tallahassee, FLIndiana University Melvin and Bren Simon Cancer Center· Indianapolis, IN

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