Neoadjuvant FOLFIRINOX Regimen in Patients With Non-metastatic Pancrease Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Baylor Research Institute
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01771146
First received: January 8, 2013
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Pancreas Cancer
Localized Pancreas Cancer
Non-metastatic Pancreas Cancer
Drug: FOLFIRINOX Regimen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • The length of time from diagnosis (enrollment) to death [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • • Overall Survival rate defined by the % of people who are alive for a certain period of time after diagnosis [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • • R0 resection as defined as microscopically negative margins [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771146

Contacts
Contact: Scott Celinski, MD 214-820-2302 scott.celinski@baylorhealth.edu
Contact: Angelia Drake, RN,BSN 214-820-2506 angelia.drake@baylorhealth.edu

Locations
United States, Texas
Baylor University Medical Center - Texas Oncology Recruiting
Dallas, Texas, United States, 75246
Contact: Scott Celinski, MD    214-820-2302    scott.celinski@Baylorhealth.edu   
Contact: Angelia Drake, RN,BSN    214-820-2506    angelia.drake@baylorhealth.edu   
Sub-Investigator: Carlos Becerra, MD         
Sub-Investigator: Keith Cavaness, MD         
Sub-Investigator: John Preskitt, MD         
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Scott Celinski, MD Baylor Health Care System
  More Information

No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01771146     History of Changes
Other Study ID Numbers: 012-180
Study First Received: January 8, 2013
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
Non-metastatic Pancreas Cancer
Pancreatic Cancer
Cancer of Pancreas
Adenocarcinoma of Pancreas
Neoadjuvant

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Oxaliplatin
Irinotecan
Camptothecin
Pancreatin
Pancrelipase
Leucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014