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Clinical Trial Record

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FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

2011-05

2013-10

2013-10

5

Study Overview

FOLFIRINOX in Patients With Inoperable Pancreatic Cancer

The prognosis of patients with locally advanced unresectable pancreatic cancer is poor, and the median survival is less than 1 year. FOLFIRINOX therapy, which induces tumor downstaging sufficient to allow surgical resection, could improve the overall survival of patients with locally advanced pancreatic cancer. Based on the FOLFIRINOX regimen for advanced pancreatic cancer, a phase II study of this regimen in patients with locally advanced unresectable and borderline pancreatic cancer is planned to determine the rate of conversion to operability.

N/A

  • Adenocarcinoma of Pancreas
  • DRUG: Irinotecan, Oxaliplatin, Leucovorin, 5-FU
  • 1977

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2011-05-23  

2017-04-14  

2018-02-23  

2011-05-23  

2018-02-23  

2018-03-09  

2011-05-24  

2018-03-09  

2018-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: FOLFIRINOX

Combination of drugs (Irinotecan, Oxaliplatin, Leucovorin, and 5-Fluorouracil (5-FU)) known as FOLFIRINOX every 2 weeks for 4 treatments. At the end of 4 cycles, patients will be re-evaluated for resectability by CT scan within 28 days of the last dose of

DRUG: Irinotecan, Oxaliplatin, Leucovorin, 5-FU

  • 5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 m
Primary Outcome MeasuresMeasure DescriptionTime Frame
To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.2 years
Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)2 years
Overall Survival2 years
Number of Participants Who Experienced Toxicity2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced unresectable or borderline resectable adenocarcinoma of pancreas
  • Patients must have measurable disease as defined by RECIST 1.1 RECIST evaluations must have occurred within 4 weeks prior to study entry
  • No evidence of hepatic or pulmonary metastatic disease by CT or CT/PET scans
  • Male or non-pregnant and non-lactating female age > or equal to 18 years and < or equal to 70 years of age
  • Patient must have received no prior therapy for the treatment of locally advanced unresectable or borderline resectable pancreatic cancer
  • Patients must have adequate blood counts at baseline and blood chemistry levels
  • Patient has ECOG Performance Status 0 to 1

    • Exclusion Criteria:

  • Patients with islet cell neoplasms excluded
  • Patients with known brain metastases
  • Therapeutic Coumadin for a history of pulmonary emboli or deep vein thrombosis (DVT)
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • Known infection with HIV, hepatitis B or hepatitis C
  • Major surgery or vascular device placement within 4 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 other clinical protocol or investigational trial
  • Metastatic disease on radiological staging
  • Prior malignancy within last 3 years
  • Significant cardiac disease
  • Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation in which in opinion of the investigator may place the patient at increased risk
  • peripheral sensory neuropathy > or equal to grade 2 at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Shubham Pant, MD, University of Oklahoma

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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