Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

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

Detailed Description
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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.

Official Title
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A Prospective Evaluation of Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancreas Cancer (Baylor University Medical Center and Texas Oncology Experience)

Conditions
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Pancreas Cancer, Localized Pancreas Cancer, Non-metastatic Pancreas Cancer

Intervention / Treatment
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* Drug: FOLFIRINOX Regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: <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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Neoadjuvant FOLFIRINOX Regimen<br>Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection | Drug: FOLFIRINOX Regimen<br>* 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 per square meter 46-hour IV infusion<br>* Other names: Adrucil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-metastatic Pancreas Cancer, Pancreatic Cancer, Cancer of Pancreas, Adenocarcinoma of Pancreas, Neoadjuvant