Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

NCT01771146 | Unknown

• 1 other identifier: 012-180
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Non-metastatic Pancreas Cancer; Pancreatic Cancer; Cancer of Pancreas; Adenocarcinoma of Pancreas; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• • 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

Study Arms (1)

Neoadjuvant FOLFIRINOX Regimen

OTHER

Single arm, treated with neoadjuvant FOLFIRINOX prior to surgical resection

Drug: FOLFIRINOX Regimen

Interventions

FOLFIRINOX Regimen 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

Also known as: FOLFIRINOX, Oxaliplatin, Irinotecan, 5-FU, Eloxatin, Camptosar, Adrucil

Neoadjuvant FOLFIRINOX Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center - Texas Oncology

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox; Oxaliplatin; Irinotecan; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Scott Celinski, MD

  Baylor Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 18, 2013
• Study Start: October 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2020
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

US (1)