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

Study Overview

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.

N/A

Pancreatic Ductal Adenocarcinoma

DRUG: modified FOLFIRINOX regimen

4-2014-0973

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-05-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-02-14
First Submitted that Met QC Criteria 2015-05-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-02-18
First Posted (ACTUAL) 2015-05-12	Results First Posted N/A	Last Verified 2019-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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

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

Primary Outcome Measures	Measure Description	Time Frame
True response rate		within 16 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival		6, 12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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Clinical Trial Record