Clinical trial NCT01771146: Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer
Official title: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Cancer
Localized Pancreas Cancer
Non-metastatic Pancreas Cancer
Keywords: Non-metastatic Pancreas Cancer
Pancreatic Cancer
Cancer of Pancreas
Adenocarcinoma of Pancreas
Neoadjuvant
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
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
timeFrame: Up to 5 years
Secondary outcomes:
measure: • The length of time from diagnosis (enrollment) to death
timeFrame: Up to 5 years
measure: • Overall Survival rate defined by the % of people who are alive for a certain period of time after diagnosis
timeFrame: Up to 5 years
measure: • R0 resection as defined as microscopically negative margins
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center - Texas Oncology
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Scott Celinski, MD
role: PRINCIPAL_INVESTIGATOR
References: