Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer
Conditions
Pancreas Cancer - Localized Pancreas Cancer - Non-metastatic Pancreas Cancer
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Non-metastatic Pancreas Cancer, Pancreatic Cancer, Cancer of Pancreas, Adenocarcinoma of Pancreas, Neoadjuvant
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: FOLFIRINOX Regimen
Type: Drug
Overall Status
Recruiting
Summary
A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Baylor University Medical Center - Texas Oncology
Dallas, Texas, United States
Status: Recruiting
Contact: Scott Celinski, MD - 214-820-2302 - scott.celinski@Baylorhealth.edu
Start Date
October 2012
Completion Date
September 2017
Sponsors
Baylor Research Institute
Source
Baylor Research Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page