Liposomal Irinotecan in Combination With Oxaliplatin, Leucovorin, and 5-fluorouracil for Patients With Locally Advanced Pancreatic Carcinoma:

Conditions

• Locally Advanced Pancreatic Carcinoma(LAPC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• FOLFOX regimen — DRUG
  FOLFOX (Oxaliplatin, Leucovorin, 5-Fluorouracil)
• Liposomal Irinotecan — DRUG
  Liposomal Irinotecan

Study Details

This is a phase II, single-arm, open-label, clinical study to investigate the efficacy and tolerability of a combination of liposomal irinotecan (nal-IRI) with oxaliplatin, leucovorin, and 5-fluorouracil (FOLFOX-nal-IRI) for treatment of patients with locally advanced pancreatic carcinoma (LAPC).

Key Dates

Start date

Sep 2, 2020

Status verified

Apr 2025

Primary completion

Aug 16, 2023

Completion

Sep 27, 2024

Study Design

Enrollment

28 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: FOLFOX + Irinotecan
  Oxaliplatin 60 mg/m2 Intravenously (IV) over 2 hours Liposomal Irinotecan (free base) 50 mg/m2 IV over 90 minutes after completion of oxaliplatin Leucovorin 400 mg/m2 IV over 30 minutes after completion of liposomal irinotecan 5-Fluorouracil 2,400 mg/m2 IV over 46 hours via infusion pump at home All drugs administered on day 1 of each 14 day cycle.

Primary Outcome Measure

Disease Control Rate (DCR) [ Time Frame: Up to 22 months ]

Locations (4)

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