Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

Not Applicable

• Conditions: Pancreas Cancer; Localized Pancreas Cancer; Non-metastatic Pancreas Cancer
• Interventions: Drug: FOLFIRINOX Regimen

• Registration Number: NCT01771146
• Lead Sponsor: Baylor Research Institute

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31
• Primary Completion: 2017-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant FOLFIRINOX Regimen	FOLFIRINOX Regimen	Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection

Primary Outcome Measures

Name	Time	Method
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	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
• R0 resection as defined as microscopically negative margins	Up to 5 years
• The length of time from diagnosis (enrollment) to death	Up to 5 years
• Overall Survival rate defined by the % of people who are alive for a certain period of time after diagnosis	Up to 5 years

Trial Locations

Locations (1)

Baylor University Medical Center - Texas Oncology; 🇺🇸 Dallas, Texas, United States