Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

Brief Summary

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

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

  • Study Type: Interventional
  • Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: September 2017

Detailed Clinical Trial Description

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.

Interventions Used in this Clinical Trial

  • 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 per square meter 46-hour IV infusion

Arms, Groups and Cohorts in this Clinical Trial

  • Other: Neoadjuvant FOLFIRINOX Regimen
    • Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
    • Time Frame: Up to 5 years
      Safety Issue?: No

Secondary Measures

  • • The length of time from diagnosis (enrollment) to death
    • Time Frame: Up to 5 years
      Safety Issue?: No
  • • Overall Survival rate defined by the % of people who are alive for a certain period of time after diagnosis
    • Time Frame: Up to 5 years
      Safety Issue?: No
  • • R0 resection as defined as microscopically negative margins
    • Time Frame: Up to 5 years
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Baylor Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Scott Celinski, MD, Principal Investigator, Baylor Health Care System
  • Overall Contact(s)
    • Scott Celinski, MD, 214-820-2302,


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