Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

NCT ID: NCT01771146

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2020-09-30

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.

Conditions

Pancreas Cancer; Localized Pancreas Cancer; Non-metastatic Pancreas Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant FOLFIRINOX Regimen

Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection

Group Type: OTHER

FOLFIRINOX Regimen

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

FOLFIRINOX; Oxaliplatin; Irinotecan; 5-FU; Eloxatin; Camptosar; Adrucil

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Celinski, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Health Care System

Locations

Baylor University Medical Center - Texas Oncology

Dallas, Texas, United States

Countries

United States

Other Identifiers

012-180

Identifier Type: -

Identifier Source: org_study_id