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Trial record 14 of 267 for:    Pancreatic Cancer AND Resectable

FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01688336
Recruitment Status : Terminated (Results unlikely to impact treatment patterns. Time to complete not justified.)
First Posted : September 19, 2012
Results First Posted : August 21, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Intervention Drug: FOLFIRINOX
Enrollment 9
Recruitment Details 11 patients were consented. One patient was consented but not treated due to metastatic disease and one patient was consented and not treated due to disease progression prior to protocol therapy. 9 patients went on study.
Pre-assignment Details  
Arm/Group Title FOLFIRINOX
Hide Arm/Group Description

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

  • Oxaliplatin (85 mg/m2)
  • Leucovorin (400mg/ m2)
  • Irinotecan (180 mg/m2)
  • Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title FOLFIRINOX
Hide Arm/Group Description

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

  • Oxaliplatin (85 mg/m2)
  • Leucovorin (400mg/ m2)
  • Irinotecan (180 mg/m2)
  • 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
63.2
(51 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
6
  66.7%
Male
3
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Hispanic or Latino
1
  11.1%
Not Hispanic or Latino
7
  77.8%
Unknown or Not Reported
1
  11.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  44.4%
White
5
  55.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
 100.0%
1.Primary Outcome
Title Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer
Hide Description All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with unresectable locally advanced pancreatic cancer.
Arm/Group Title FOLFIRINOX
Hide Arm/Group Description:

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

  • Oxaliplatin (85 mg/m2)
  • Leucovorin (400mg/ m2)
  • Irinotecan (180 mg/m2)
  • 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
Overall Number of Participants Analyzed 5
Median (95% Confidence Interval)
Unit of Measure: months
28.5 [1] 
(6.2 to NA)
[1]
Insufficient number of participants with events
2.Secondary Outcome
Title Overall Survival for Borderline Resectable Patients
Hide Description All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the outcome of overall survival (OS)
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOLFIRINOX
Hide Arm/Group Description:

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

  • Oxaliplatin (85 mg/m2)
  • Leucovorin (400mg/ m2)
  • Irinotecan (180 mg/m2)
  • 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
Overall Number of Participants Analyzed 4
Median (95% Confidence Interval)
Unit of Measure: Months
9.0
(5.8 to 16.2)
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression free survival will be measured from D1 of treatment until evidence of tumor progression (including clinical deterioration related to the underlying pancreatic cancer, as assessed by the investigator) or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are lost to follow-up will be censored
Time Frame the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOLFIRINOX
Hide Arm/Group Description:

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

  • Oxaliplatin (85 mg/m2)
  • Leucovorin (400mg/ m2)
  • Irinotecan (180 mg/m2)
  • 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
Overall Number of Participants Analyzed 9
Median (95% Confidence Interval)
Unit of Measure: Months
10.7
(2.0 to 24.8)
4.Secondary Outcome
Title Objective Response Rate
Hide Description

All patients who have received at least one cycle of treatment will be evaluated. Disease will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

Patients who drop out of the study prior to disease evaluation will not be evaluable for response unless the patient undergoes radiologic evaluation or their disease progresses clinically.

Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOLFIRINOX
Hide Arm/Group Description:

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

  • Oxaliplatin (85 mg/m2)
  • Leucovorin (400mg/ m2)
  • Irinotecan (180 mg/m2)
  • 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
Overall Number of Participants Analyzed 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
11
(0 to 48)
5.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description Disease control rate will be measured by the percentage of patients with responses (CR) and partial responses (PR) and stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); Complete Response (CR), Disappearance of all target lesions.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOLFIRINOX
Hide Arm/Group Description:

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

  • Oxaliplatin (85 mg/m2)
  • Leucovorin (400mg/ m2)
  • Irinotecan (180 mg/m2)
  • 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
Overall Number of Participants Analyzed 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
89
(52 to 100)
6.Secondary Outcome
Title Rate of Resectability (RR)
Hide Description Rate of resectability will be evaluated by determining the percentage of patients who were initially deemed to have ULA or borderline resectable (BR) disease and, following any period of treatment, were subsequently deemed to have resectable disease and undergo surgical resection. The denominator will reflect all patients with ULA or BR disease.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOLFIRINOX
Hide Arm/Group Description:

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

  • Oxaliplatin (85 mg/m2)
  • Leucovorin (400mg/ m2)
  • Irinotecan (180 mg/m2)
  • 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
Overall Number of Participants Analyzed 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
22
(0 to 60)
7.Other Pre-specified Outcome
Title Correlation of Tumor Markers (Ca19-9, CEA) With Outcomes (RR, DCR, PFS, and OS).
Hide Description Tumor markers (Ca19-9, CEA) will be measured at baseline, every eight weeks and at end of treatment, and will be correlated with outcomes resectability response (RR),disease control rate (DCR), progression free survival (PFS) and overall survival (OS).
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title FOLFIRINOX
Hide Arm/Group Description:

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

  • Oxaliplatin (85 mg/m2)
  • Leucovorin (400mg/ m2)
  • Irinotecan (180 mg/m2)
  • Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FOLFIRINOX
Hide Arm/Group Description

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

  • Oxaliplatin (85 mg/m2)
  • Leucovorin (400mg/ m2)
  • Irinotecan (180 mg/m2)
  • 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
All-Cause Mortality
FOLFIRINOX
Affected / at Risk (%)
Total   7/9 (77.78%) 
Show Serious Adverse Events Hide Serious Adverse Events
FOLFIRINOX
Affected / at Risk (%)
Total   2/9 (22.22%) 
General disorders   
Death * 1 [1]  1/9 (11.11%) 
Infections and infestations   
Urinary Tract Infection * 1  1/9 (11.11%) 
Renal and urinary disorders   
Renal Calculi * 1  1/9 (11.11%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
[1]
Sudden death not otherwise specified (NOS)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FOLFIRINOX
Affected / at Risk (%)
Total   9/9 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  7/9 (77.78%) 
Gastrointestinal disorders   
Abdominal Pain * 1  3/9 (33.33%) 
Anorexia * 1  1/9 (11.11%) 
Diarrhea * 1  4/9 (44.44%) 
Mucositis Oral * 1  2/9 (22.22%) 
Nausea * 1  4/9 (44.44%) 
Vomiting * 1  1/9 (11.11%) 
General disorders   
Chills * 1  1/9 (11.11%) 
Edema Limbs * 1  1/9 (11.11%) 
Fatigue * 1  4/9 (44.44%) 
Fever * 1  1/9 (11.11%) 
Infections and infestations   
Vaginal Infection * 1  1/9 (11.11%) 
Investigations   
Alanine Aminotransferase Increased * 1  3/9 (33.33%) 
Alkaline Phosphatase Increased * 1  6/9 (66.67%) 
Aspartate Aminotransferase Increased * 1  3/9 (33.33%) 
Blood Bilirubin Increased * 1  1/9 (11.11%) 
Creatinine Increased * 1  2/9 (22.22%) 
Ggt Increased * 1  5/9 (55.56%) 
Lipase Increased * 1  1/9 (11.11%) 
Lymphocyte Count Decreased * 1  2/9 (22.22%) 
Neutrophil Count Decreased * 1  8/9 (88.89%) 
Platelet Count Decreased * 1  6/9 (66.67%) 
White Blood Cell Decreased * 1  5/9 (55.56%) 
Metabolism and nutrition disorders   
Hyperglycemia * 1  1/9 (11.11%) 
Hypermagnesemia * 1  1/9 (11.11%) 
Hypertriglyceridemia * 1  5/9 (55.56%) 
Hyperuricemia * 1  4/9 (44.44%) 
Hypoalbuminemia * 1  6/9 (66.67%) 
Hypocalcemia * 1  4/9 (44.44%) 
Hypokalemia * 1  5/9 (55.56%) 
Hypomagnesemia * 1  3/9 (33.33%) 
Hypophosphatemia * 1  1/9 (11.11%) 
Nervous system disorders   
Dysgeusia * 1  1/9 (11.11%) 
Peripheral Sensory Neuropathy * 1  4/9 (44.44%) 
Syncope * 1  1/9 (11.11%) 
Psychiatric disorders   
Insomnia * 1  1/9 (11.11%) 
Renal and urinary disorders   
Proteinuria * 1  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Postnasal Drip * 1  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Rash Maculo-Papular * 1  1/9 (11.11%) 
Vascular disorders   
Hypertension * 1  2/9 (22.22%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
EMail: Robin_V_Johnson@med.unc.edu
Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01688336     History of Changes
Other Study ID Numbers: LCCC 1105
First Submitted: September 14, 2012
First Posted: September 19, 2012
Results First Submitted: July 21, 2017
Results First Posted: August 21, 2017
Last Update Posted: October 6, 2017