A Pilot Study of Pre- and Post-surgery Chemotherapy With mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma

Part of paid clinical trials in Evanston, Illinois.

Sponsor
Endeavor Health
Study ID
NCT01660711
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 5 Fluorouracil — DRUG
    2400 mg/m2 by continuous intravenous infusion over 46 hours
  • Leucovorin — DRUG
    400 mg/m2 by IV infusion over 2 hours
  • Irinotecan — DRUG
    180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin)
  • Oxaliplatin — DRUG
    85 mg/m² IV infusion on Day 1 over 2 hours

Study Details

The purpose of the study is to demonstrate that it is possible to administer chemotherapy prior to and following surgery for pancreatic cancer which is considered operable. The chemotherapy chosen is that which has been shown to be the most effective in treating metastatic disease, and the goal is both to investigate whether this is tolerable and also to investigate the efficacy of this approach in terms of disease response and survival.

Key Dates

Start date
Jul 31, 2012
Status verified
Nov 2021
Primary completion
Aug 22, 2018
Completion
Aug 22, 2018

Study Design

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

Arms

  • Experimental: FOLFIRINOX chemotherapy
    5FU 2400 mg/m2 IV over 48 hours Irinotecan 180 mg/m2 IV day 1 Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1 Cycles administered every 14 days for 4 cycles before and 4 cycles after surgery.

Primary Outcome Measure

Percentage Able to Complete Full Course of Preoperative Chemotherapy [ Time Frame: Following completion of all planned therapy, an expected average of 4 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
NorthShore University HealthSystemEvanstonIllinois60201-

Find similar trials in Evanston, IL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
NorthShore University HealthSystem· Evanston, IL

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