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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00463840
Recruitment Status : Terminated (Due to slow accrual)
First Posted : April 20, 2007
Results First Posted : May 1, 2012
Last Update Posted : December 5, 2017
Information provided by (Responsible Party):
NYU Langone Health

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Oxaliplatin Drug: 5FU Radiation: Radiation Procedure: Surgery Drug: FOLFOX 6 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer
Study Start Date : June 2004
Actual Primary Completion Date : July 2010
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

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 Name: Oxaliplatin: Eloxatin

Drug: 5FU
Other Name: 5-Fluorouracil

Radiation: Radiation
Procedure: Surgery
Drug: FOLFOX 6
this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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 .

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00463840

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United States, New York
Bellevue Hospital
New York, New York, United States, 10016
NYU Cancer Institute
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
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Principal Investigator: Theresa Ryan, MD NYU Langone Health

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Responsible Party: NYU Langone Health Identifier: NCT00463840    
Other Study ID Numbers: 03-64
H11640 ( Other Identifier: NYU )
Sanofi-Aventis 0x 03-030 ( Other Identifier: Sanofi-Aventis )
First Posted: April 20, 2007    Key Record Dates
Results First Posted: May 1, 2012
Last Update Posted: December 5, 2017
Last Verified: October 2017
Keywords provided by NYU Langone Health:
Locally advanced pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs