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