Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

Sponsor

Baylor Research Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT01771146

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer Localized Pancreas Cancer Non-metastatic Pancreas Cancer	Drug: FOLFIRINOX Regimen	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Sep 1, 2017

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Neoadjuvant FOLFIRINOX Regimen Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection	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 Other Names: FOLFIRINOX Oxaliplatin Irinotecan 5-FU Eloxatin Camptosar Adrucil

Arm

Intervention/Treatment

Other: Neoadjuvant FOLFIRINOX Regimen

Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection

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

Other Names:

FOLFIRINOX

Oxaliplatin

Irinotecan

5-FU

Eloxatin

Camptosar

Adrucil

Outcome Measures

Primary Outcome Measures

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

• 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]
• R0 resection as defined as microscopically negative margins [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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