Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01771146
• Other study ID #: 012-180
• Status: Active, not recruiting
• Phase: N/A
• First received: January 8, 2013
• Last updated: January 30, 2017
• Start date: October 2012
• Est. completion date: September 2020

Study information

• Verified date: January 2017
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective evaluation of neoadjuvant FOLFIRINOX regimen in patients with non-metastatic pancreas cancer (Baylor University Medical Center and Texas Oncology Experience)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2020
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• FOLFIRINOX Regimen
6 cycles of FOLFIRINOX prior to surgical resection: Eloxatin® (Oxaliplatin) 85 mg per square meter 2-hour IV infusion Camptosar® (Irinotecan Hydrochloride) 180 mg per square meter 90-minute IV infusion via Y-connector adrucil (Fluorouracil; 5-FU)2400 mg per square meter 46-hour IV infusion

Locations

Country	Name	City	State
United States	Baylor University Medical Center - Texas Oncology	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	• The length of time from diagnosis (enrollment) to death		Up to 5 years
Secondary	• Overall Survival rate defined by the % of people who are alive for a certain period of time after diagnosis		Up to 5 years
Secondary	• R0 resection as defined as microscopically negative margins		Up to 5 years