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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)


N/A
18 Years
N/A
Open (Enrolling)
Both
Localized Pancreas Cancer, Non-metastatic Pancreas Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Scott Celinski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor Health Care System

Authority:

United States: Institutional Review Board

Study ID:

012-180

NCT ID:

NCT01771146

Start Date:

October 2012

Completion Date:

September 2017

Related Keywords:

  • Localized Pancreas Cancer
  • Non-metastatic Pancreas Cancer
  • Non-metastatic Pancreas Cancer
  • Pancreatic Cancer
  • Cancer of Pancreas
  • Adenocarcinoma of Pancreas
  • Pancreatic Neoplasms

Name

Location

Baylor University Medical Center - Texas OncologyDallas, Texas  75246