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

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxaliplatin
5FU
Radiation
Surgery
FOLFOX 6
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Locally advanced pancreatic cancer, oxaliplatin, chemoradiation, 5FU

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bellevue Hospital
  • NYU Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2007
Last Updated
October 30, 2017
Sponsor
NYU Langone Health
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00463840
Brief Title
Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer
Official Title
A Phase I/II Study of Chemoradiation With Oxaliplatin and 5FU for Locally Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to slow accrual
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Locally advanced pancreatic cancer, oxaliplatin, chemoradiation, 5FU

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxaliplatin+ 5FU+ radiation (RT) /surgery /FOLFOX 6
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Oxaliplatin: Eloxatin
Intervention Type
Drug
Intervention Name(s)
5FU
Other Intervention Name(s)
5-Fluorouracil
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Type
Drug
Intervention Name(s)
FOLFOX 6
Intervention Description
this is an established regimen of Oxaliplatin+infusional 5FU/Leucovorin
Primary Outcome Measure Information:
Title
Resectability After Chemoradiation
Description
This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).
Time Frame
7.5 weeks
Secondary Outcome Measure Information:
Title
Median Overall Survival
Description
This is the time at which 50% of patients are alive from the trial entry .
Time Frame
up to 10 years since the start of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Ryan, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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

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