Modified FOLFIRINOX for Gemcitabine Refractory Pancreatic Cancer: A Phase II Multicenter Trial

Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis. Since the approval of gemcitabine as a standard treatment for advanced pancreatic patients, no drug or combination of drugs has significantly improved the prognosis. Recently, as compared with gemcitabine, FOLFIRINOX was associated with a survival advantage (11.1 vs 6.8 months), but had increased toxicity. In some retrospective studies, modified FOLFIRINOX regimen (60/120 mg/m2 of oxaliplatin and irinotecan) has an improved safety profile in digestive malignancies. The purpose of this phase II multicenter study was to investigate the efficacy and safety in patients with pancreatic cancer who progressed in gemcitabine-based first line chemotherapy.

Study Overview

• Status: Completed
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: modified FOLFIRINOX regimen

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally advanced stage)
• Refractory or progress to Gemcitabine based 1st line chemotherapy
• Older than 19 years old and younger than 75 years old
• Life expectancy> 3 months
• ECOG Performance status ≤2
• Only patients with measurable lesions in imaging study
• Adequete BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
• Adequete liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement)
• Adequete renal function (serum creatinine < 1.5 mg/dl)
• Adequete cardiopulmonary function

Exclusion Criteria:

• Pathologically confirmed another type of pancreatic cancer (except ductal adenocarcinoma)
• Metastatic adenocarcinoma of originating at other organs
• Evidence with CNS metastasis
• Active infection
• Uncontrolled serious medical or psychiatric illness which can induce toxicity ro complication of treatment, such as inability to swallow, lacking physical integrity of the gastrointestinal tract, malabsorption syndrome, or active ulceration at upper gastrointestinal tract.
• Coexisting of other malignancies within 5 years, except squamous cell carcinoma and basal cell carcinoma of the skin
• Participation in any other investigational drug study within 1 month
• No signed informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: modified FOLFIRINOX

Drug: modified FOLFIRINOX regimen; Modified FOLFIRINOX regimen consisted of oxaliplatin at a dose of 60 mg per square meter, given as a 2-hour intravenous infusion, after 60 minutes, of irinotecan at a dose of 120 mg per square meter, given as a 90-minute intravenous infusion, immediately followed by leucovorin at a dose of 400 mg per square meter, given as a 2-hour intravenous infusion through a Y-connector. This treatment was immediately followed by fluorouracil at a dose of 400 mg per square meter, administered by intravenous bolus, followed by a continuous intravenous infusion of 2400 mg per square meter over a 46-hour period every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
True response rate	within 16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	6, 12 months

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: August 28, 2015
• Primary Completion (Actual): March 2, 2017
• Study Completion (Actual): March 2, 2017

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Antineoplastic Agents; Folfirinox
• Other Study ID Numbers: 4-2014-0973