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Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer (FOLFIRINOX)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523457
First Posted: February 1, 2012
Last Update Posted: August 30, 2017
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.
Information provided by (Responsible Party):
Yale University
Results First Submitted: September 1, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Metastatic Pancreatic Cancer
Pancreatic Cancer
Intervention: Drug: Folfirinox

  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
Patients with pathologically confirmed, measurable or non-measurable assessable MPC or LAPC (including unresectable and borderline resectable) were recruited from November 2011 through January 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MPC Modified FOLFIRINOX Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
LAPC Modified FOLFIRINOX Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.

Participant Flow:   Overall Study
    MPC Modified FOLFIRINOX   LAPC Modified FOLFIRINOX
STARTED   44   31 
COMPLETED   37   29 
NOT COMPLETED   7   2 
Withdrawal by Subject                7                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
75 patients, including 44 with MPC and 31 with LAPC, were enrolled. The demographics and disease characteristics of the 37 evaluable patients in the MPC cohort in this study are presented here. Seven of 44 patients with MPC were excluded from efficacy analysis due to voluntary withdrawal.

Reporting Groups
  Description
MPC Modified FOLFIRINOX Patients with metastatic pancreatic cancer (MPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
LAPC Modified FOLFIRINOX Patients with locally advanced pancreatic cancer (LAPC) were treated with modified FOLFIRINOX every 2 weeks as follows: oxaliplatin 85 mg m 2 infused over 120 min, immediately followed by folinic acid 400 mg m 2 infused over 120 min with the addition, after 30 min, of irinotecan 135 mg m 2 infused over 90 min, followed by 5FU 300 mg m 2 IV bolus, followed by 2400 mg m 2 continuous infusion for 46 h (25% reduction in bolus 5FU and irinotecan doses). All patients received pegylated filgrastim with each cycle on day 3 or 4 in the absence of severe leukocytosis. All patients routinely received palonosetron, aprepitant and dexamethasone for emesis prophylaxis.
Total Total of all reporting groups

Baseline Measures
   MPC Modified FOLFIRINOX   LAPC Modified FOLFIRINOX   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   31   68 
Age, Customized 
[Units: Years]
Median (Full Range)
     
Age   62 
 (50 to 77) 
 63 
 (46 to 79) 
 62 
 (46 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      16  43.2%      11  35.5%      27  39.7% 
Male      21  56.8%      20  64.5%      41  60.3% 
ECOG Performance Status 
[Units: Participants]
     
0: Fully active   17   15   32 
1: Restricted in physically strenuous activity   20   16   36 
Pancreatic tumour location [1] 
[Units: Participants]
     
Head   17   27   44 
Body   14   4   18 
Tumour Resection   6   0   6 
[1] Location of the pancreatic tumour in either the head or body of the pancreas. Six subjects had their pancreatic tumour resected (so it is no longer located in the pancreas), but still qualified for the metastatic arm.
Level of CA19.9 [1] 
[Units: Participants]
     
Normal   4   3   7 
Elevated, <59 Upper Limits of Normal   18   24   42 
Elevated, >=59 Upper Limits of Normal   15   4   19 
[1] CA 19-9 (carbohydrate antigen 19-9 is a tumor marker that is used primarily in the management of pancreatic cancer. Changes in CA 19-9 levels help determine if the tumor is growing, remaining stable or getting smaller.
Biliary stent 
[Units: Participants]
     
Yes   9   17   26 
No   28   14   42 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival   [ Time Frame: 24 weeks ]

2.  Secondary:   Objective Response Rate   [ Time Frame: 24 weeks ]

3.  Secondary:   Overall Survival   [ Time Frame: 24 weeks ]

4.  Secondary:   Toxicity   [ Time Frame: 24 weeks ]

5.  Secondary:   Rate of Resection in Patients With Locally Advanced Disease   [ Time Frame: 24 weeks ]

6.  Secondary:   Correlate Time to Progression, Objective Response, and Overall Survival With Early Changes in Glucose Metabolism Using FDG-positron Emission Tomography (PET) Scanning   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jill Lacy
Organization: Yale University
phone: +1 (203) 737-1600
e-mail: jill.lacy@yale.edu


Publications of Results:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01523457     History of Changes
Other Study ID Numbers: 1108008901
First Submitted: January 23, 2012
First Posted: February 1, 2012
Results First Submitted: September 1, 2016
Results First Posted: August 30, 2017
Last Update Posted: August 30, 2017