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Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Baylor Research Institute Identifier:
First received: January 8, 2013
Last updated: January 30, 2017
Last verified: January 2017
A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)

Condition Intervention
Pancreas Cancer
Localized Pancreas Cancer
Non-metastatic Pancreas Cancer
Drug: FOLFIRINOX Regimen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancreas Cancer (Baylor University Medical Center and Texas Oncology Experience)

Resource links provided by NLM:

Further study details as provided by Baylor Research Institute:

Primary Outcome 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 ]

Secondary Outcome Measures:
  • • The length of time from diagnosis (enrollment) to death [ Time Frame: Up to 5 years ]
  • • 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 ]
  • • R0 resection as defined as microscopically negative margins [ Time Frame: Up to 5 years ]

Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 per square meter 46-hour IV infusion
Other Names:
  • Oxaliplatin
  • Irinotecan
  • 5-FU
  • Eloxatin
  • Camptosar
  • Adrucil

Detailed 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01771146

United States, Texas
Baylor University Medical Center - Texas Oncology
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Principal Investigator: Scott Celinski, MD Baylor Health Care System
  More Information

Responsible Party: Baylor Research Institute Identifier: NCT01771146     History of Changes
Other Study ID Numbers: 012-180
Study First Received: January 8, 2013
Last Updated: January 30, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Baylor Research Institute:
Non-metastatic Pancreas Cancer
Pancreatic Cancer
Cancer of Pancreas
Adenocarcinoma of Pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex processed this record on April 28, 2017