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Pancreatic CancerPhase 1/2NCT00463840

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

A Phase 1/2 study testing Oxaliplatin, 5FU and Radiation in people with Pancreatic Cancer, run by NYU Langone Health at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Oxaliplatin, 5FU and Radiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
Jun 2004to Oct 2015
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Bellevue Hospital

    New York, New York, 10016

  • NYU Cancer Institute

    New York, New York, 10016

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Oxaliplatin, 5FU, Radiation, Surgery, FOLFOX 6
Keywords
Locally advanced pancreatic cancer, oxaliplatin, chemoradiation, 5FU
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    Also called Oxaliplatin: Eloxatin

  • 5FUDrug

    Also called 5-Fluorouracil

  • RadiationRadiation

  • SurgeryProcedure or surgery

  • FOLFOX 6Drug

    this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin

Study groups in NCT00463840
Study groupRoleWhat they receive
Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6ExperimentalConcurrent 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.
Receives: Drug: Oxaliplatin; Drug: 5FU; Radiation: Radiation; Procedure: Surgery; Drug: FOLFOX 6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resectability After Chemoradiation

    This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).

    Measured: 7.5 weeks

Secondary outcomes (1)

  1. Median Overall Survival

    This is the time at which 50% of patients are alive from the trial entry .

    Measured: up to 10 years since the start of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2007 (estimated)
  2. Study startJun 2004
  3. Primary completionJul 2010
  4. Study completionOct 2015

Why it stopped: Due to slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00463840
Sponsor's protocol ID
03-64
Other IDs
H11640, Sanofi-Aventis 0x 03-030
Status last verified
Oct 2017
First submitted
18 Apr 2007
Last updated
5 Dec 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oxaliplatin, 5FU and Radiation in people with Pancreatic Cancer, run by NYU Langone Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resectability After Chemoradiation (time frame: 7.5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00463840.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.

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