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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00463840
First received: April 18, 2007
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
Results First Received: March 5, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: Oxaliplatin
Drug: 5FU
Radiation: Radiation
Procedure: Surgery
Drug: FOLFOX 6

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Total 24 patients were enrolled to this Ph I/II study between June 2004 and December 2009 at New York University Medical Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The efficacy and toxicity data were based on both Ph I and II.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6  
STARTED     24  
COMPLETED     12  
NOT COMPLETED     12  
Disease progression                 7  
Withdrawal by Subject                 2  
Adverse Event                 3  



  Baseline Characteristics
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Reporting Groups
  Description
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.

Baseline Measures
    Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6  
Number of Participants  
[units: participants]
 		  24  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     9  
Age  
[units: years]
Median ( Full Range ) 		  63.7  
  ( 46 to 76 )  
Gender  
[units: participants]
 		 
Female     10  
Male     14  
Region of Enrollment  
[units: participants]
 		 
United States     24  



  Outcome Measures

1.  Primary:   Resectability After Chemoradiation   [ Time Frame: 7.5 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Median Overall Survival   [ Time Frame: up to 10 years since the start of the study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study did not reach its target accrual due to slow accrual. Small number of patients were analyzed.  


Results Point of Contact:  
Name/Title: Theresa Ryan, MD
Organization: New York University Cancer Institute
phone: 212-731-5430
e-mail: theresa.ryan@nyumc.org


No publications provided


Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00463840     History of Changes
Other Study ID Numbers: 03-64, H11640, Sanofi-Aventis 0x 03-030
Study First Received: April 18, 2007
Results First Received: March 5, 2012
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration