A Study of Nal-IRI With 5-FU, Levofolinic Acid and Oxaliplatin in Patients With Resectable Pancreatic Cancer

Sponsor
Centro Ricerche Cliniche di Verona
Study ID
NCT03528785
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Liposomal Injection [Onivyde]; oxaliplatin, 5-FU; Levofolinic Acid — DRUG
    * Oxaliplatin 60 mg/m2 IV in 120 minutes) on Days 1 and 15 of each cycle * Irinotecan Liposomal Injection \[Onivyde\] (60 mg/m2 IV over 90 minutes) on Days 1 and 15 of each cycle * Levofolinic acid (200 mg/m2 IV over 30 minutes) on Days 1 and 15 of each cycle * 5FU (2.400 mg/m2 IV over 46 hours) on Days 1 and 15 of each cycle

Study Details

Rational:Pancreatic cancer is a systemic disease at the time of diagnosis, even among patients with apparent localized disease. Surgical resection is the only potentially curative therapy for pancreatic cancer, but in patients who undergo surgery and postoperative therapy, metastatic relapse remains common and no more than 20% of patients achieve 5-year survival. Because of this aggressive biologic behavior, an increasing interest is growing about preoperative treatments in resectable pancreatic cancer. The combination chemotherapeutic regimen with irinotecan + 5-fluorouracil (5-FU)/leucovorin (LV) + oxaliplatin (FOLFIRINOX) is an effective choice for first line treatment in patients affected by advanced pancreatic cancer, and in this setting it achieved a Disease Control Rate of 70.2 % (10). In this regard, FOLFIRINOX is currently explored as preoperative regimen in a number of clinical trials in resectable pancreatic cancer. A critical challenge in this field remains the introduction in these combination treatments of the most novel and effective agents such as nalIRI, in order to obtain a more profound tumor shrinkage, to increase the rate of R0 resections, to allow an early treatment of occult micrometastatic disease, and eventually, to improve survival in patients with resectable pancreatic cancer. This study proposal is designed to address this challenge. Preliminary results, collected during the Part 1 Dose Escalation of a current clinical trial performed in mPDAC, show that dose of nal-IRI: 60 mg/m2, Oxaliplatin: 60 mg/m2, 5-FU/LV: 2400/400 mg/m2 is safe.

Key Dates

Start date
Mar 2, 2018
Status verified
Jul 2021
Primary completion
Nov 15, 2021
Completion
Nov 1, 2022

Study Design

Enrollment
67 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    All patients will receive a treatment scheme of Irinotecan Liposomal Injection \[Onivyde\], oxaliplatin, Levofolinic Acid and 5-fluorouracil (5 -FU) on Day 1 and Day 15 of each 28 day cycles.

Primary Outcome Measure

Number of patients achieving R0 resection after preoperative nanoliposomal irinotecan (nal-IRI), Oxaliplatin, Leucovorin (LV), 5-FluoroUracil (5-FU) [ Time Frame: 4-8 weeks after the completion of 3 courses of treatment ]

Central Contacts

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