Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer

October 30, 2017 updated by: NYU Langone Health

A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer

The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Previous studies have demonstrated that neoadjuvant chemoradiation can lead to improved survival with a portion of patients proceeding to resection. This trial will incorporate a similar trial structure using newer agents in patients who present with locally advanced unresectable pancreatic cancer. Specifically oxaliplatin will be used owing to its greater activity in comparison to cisplatin and favorable therapeutic index in combination with radiation compared to gemcitabine.

In summary, the primary outcome measure of the phase I portion of the trial is to determine the maximum tolerated dose of this combination. Following the determination of this dose, the phase II portion of the trial will characterize the toxicity of this regimen as well as evaluate for long-term efficacy.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Bellevue Hospital
      • New York, New York, United States, 10016
        • NYU Cancer Institute

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically documented pancreatic adenocarcinoma deemed unresectable due to local involvement of vessels or organs
  • Patients with a clear clinical diagnosis of localized pancreatic cancer deemed unresectable, who have undergone at least 2 biopsies which were not diagnostic of adenocarcinoma, may be entered at the discretion of the principal investigator.
  • No prior chemotherapy or abdominal radiation therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Clinically measurable or evaluable disease.
  • Life expectancy of at least 12 weeks.
  • Adequate bone marrow reserve, granulocyte count >= 1500/uL, platelet count >= 100,000/uL, hemoglobin >= 9 g/dL.
  • Adequate renal function with creatinine =< 1.5 times upper limit of normal (ULN)
  • Adequate biliary function with bilirubin < 3.0 g/dL (including patients who have been bypassed or treated with percutaneous drainage), serum glutamic pyruvic transaminase (SGPT) (alanine transaminase) =< 2.5
  • Age > 18 years
  • Signed informed consent.
  • No known allergy to one of the study drugs
  • For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
  • No prior malignancy within last 5 years
  • No central nervous system metastases
  • No peripheral neuropathy > grade2
  • No other serious concomitant illness

Exclusion Criteria:

  • Active infection or uncontrolled infection
  • Presence of metastatic disease.
  • Inadequate organ function as discussed above.
  • Pregnancy
  • Serious concomitant systemic disorder.
  • Use of any investigational agent within a month of treatment

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6

Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery

Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;

Combined with :

5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).

Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.

Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):

Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours.
Drug: Oxaliplatin
Other Names:
  • Oxaliplatin: Eloxatin
Procedure: Surgery
Radiation: Radiation
Drug: 5FU
Other Names:
  • 5-Fluorouracil
Drug: FOLFOX 6
this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resectability After Chemoradiation
Time Frame: 7.5 weeks
This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).
7.5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Overall Survival
Time Frame: up to 10 years since the start of the study
This is the time at which 50% of patients are alive from the trial entry .
up to 10 years since the start of the study

Collaborators and Investigators

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

Sponsor

NYU Langone Health

Collaborators

Sanofi

Investigators

  • Principal Investigator: Theresa Ryan, MD, NYU Langone Health

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 Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 18, 2007

First Submitted That Met QC Criteria

April 18, 2007

First Posted (Estimate)

April 20, 2007

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-64
  • H11640 (Other Identifier: NYU)
  • Sanofi-Aventis 0x 03-030 (Other Identifier: Sanofi-Aventis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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