Neoadjuvant FOLFIRINOX Regimen In Patients With Non-metastatic Pancrease Cancer

Study Overview

Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)

Patients with pancreas cancer will be enrolled and treated with a planned course of 6 cycles (3 months) of chemotherapy with FOLFIRINOX prior to undergoing surgical resection.

Pancreas Cancer
Localized Pancreas Cancer
Non-metastatic Pancreas Cancer

DRUG: FOLFIRINOX Regimen

012-180

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 2013-01-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-01-30
First Submitted that Met QC Criteria 2013-01-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2017-01-31
First Posted (ESTIMATED) 2013-01-18	Results First Posted N/A	Last Verified 2017-01

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
OTHER: Neoadjuvant FOLFIRINOX Regimen Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection	DRUG: FOLFIRINOX Regimen 6 cycles of FOLFIRINOX prior to surgical resection: Eloxatin® (Oxaliplatin) 85 mg per square meter 2-hour IV infusion Camptosar® (Irinotecan Hydrochloride) 180 mg per square meter 90-minute IV infusion via Y-connector adrucil (Fluorouracil; 5-FU)2400 mg p

Participant Group/Arm

Intervention/Treatment

OTHER: Neoadjuvant FOLFIRINOX Regimen

Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection

DRUG: FOLFIRINOX Regimen

6 cycles of FOLFIRINOX prior to surgical resection: Eloxatin® (Oxaliplatin) 85 mg per square meter 2-hour IV infusion Camptosar® (Irinotecan Hydrochloride) 180 mg per square meter 90-minute IV infusion via Y-connector adrucil (Fluorouracil; 5-FU)2400 mg p

Primary Outcome Measures	Measure Description	Time Frame
Progression Free Survival (PFS) as defined by the length of time that a patient survives without any signs or symptoms of that cancer or any other type of cancer		Up to 5 years

Secondary Outcome Measures	Measure Description	Time Frame
• The length of time from diagnosis (enrollment) to death		Up to 5 years
• Overall Survival rate defined by the % of people who are alive for a certain period of time after diagnosis		Up to 5 years
• R0 resection as defined as microscopically negative margins		Up to 5 years

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:
18 Years

Accepts Healthy Volunteers:

18 years of age or older
Male or non-pregnant and non-lactating female
Histologically or cytologically confirmed adenocarcinoma of pancreas
Patients must have satisfactory blood counts and blood chemistry levels at baseline (refer to Appendix 2, Study Laboratory References Range).
Patient has Eastern Cooperative Oncology Group(ECOG) Performance Status 0 to 1 (refer to Appendix 7):
0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
1 - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
Signed study consent form

<18 years of age
Pregnant or lactating female
Patient has islet cell neoplasms
Patient has known brain metastases
Patient has metastatic disease
Active secondary malignancies
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Known infection with hepatitis B, hepatitis C, or cirrhosis
Major surgery or vascular device placement (excluding ports for IV medication/chemotherapy) within 2 weeks prior to Day 1 of treatment in study
Prior chemotherapy or radiation for pancreatic cancer
History of allergy or hypersensitivity to the study drugs
Patient is enrolled in any outside (outside Baylor University Medical Center or Texas Oncology) clinical protocol or investigational trial
Significant cardiac disease as defined as New York Heart Association (NYHA) classification III or IV, uncontrolled congestive heart failure (CHF), or prior myocardial infarction (MI) last 6-months
Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation which in the opinion of the investigator may place the patient at increased risk
Peripheral sensory neuropathy ≥ to grade 2 at baseline
Significant co-morbidities deemed by investigator as unsuitable for participation/enrollment
Study consent form not signed

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Scott Celinski, MD, Baylor Health Care System

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record