Trial Outcomes & Findings for Efficacy and Tolerance Evaluation in FOLFIRINOX Dose Adjusted in Elderly Patients With a Metastatic Pancreatic Cancer (NCT NCT02143219)
NCT ID: NCT02143219
Last Updated: 2026-04-15
Results Overview
This outcome is a composite assessment combining safety and early efficacy signals in the first 34 enrolled patients. Safety is measured by the occurrence of grade ≥3 toxicities (NCI-CTCAE v4.0). Early efficacy is assessed by the presence or absence of tumor response according to predefined stopping rules. Both components contribute jointly to the decision-making criteria for continuation of the study. This description corresponds specifically to the data reported in the Results section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
From treatment initiation through Week 12
Results posted on
2026-04-15
Participant Flow
Participant milestones
| Measure |
FOLFIRINOX
FOLFIRINOX (D1-D15, for maximum 12 cycles) = Oxaliplatine + Folinic acid + Irinotecan + 5-FU
Oxaliplatine: Oxaliplatine : 85mg/m², 2-hours IV infusion (D1),
Folinic acid: Folinic acid (FA): 400 mg/m² , 2-hour IV infusion (D1),
Irinotecan: Irinotecan (at the dosage determined by the UGT1A1 status), 90 min IV infusion starting 30 min after the FA starts
* Homozygous 6/6 or 6/7: irinotecan will start at 150 mg/m², then will be increased according to clinical/biological tolerance by 10% steps, at each cycle, up to 180 mg/m² at max.
* Homozygous 7/7: irinotecan will start at 130 mg/m² in the first cycle then be increased up to a max of 150 mg/m², by 10% steps, according to tolerance.
5-FU: 5-FU (according to the DPD pharmacogenetic status), continuous IV infusion of 46 hours, starting at the end of FA infusion:
* If no DPD deficiency, 5-FU start at 1600 mg/m² and can be modulated according to clinical/biological tolerance after each course, i.e., 1800 mg/m² the 2nd course and 2000 mg/m² the 3rd one
* If partial DPD deficiency: 5-FU start at 1200 mg/m² and can be increased up to 1800, then 2000 if the clinical/biological tolerance are good at the 2nd and 3rd course.
|
|---|---|
|
Overall Study
STARTED
|
69
|
|
Overall Study
COMPLETED
|
69
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
FOLFIRINOX
n=69 Participants
FOLFIRINOX (D1-D15, for maximum 12 cycles) = Oxaliplatine + Folinic acid + Irinotecan + 5-FU
Oxaliplatine: Oxaliplatine : 85mg/m², 2-hours IV infusion (D1),
Folinic acid: Folinic acid (FA): 400 mg/m² , 2-hour IV infusion (D1),
Irinotecan: Irinotecan (at the dosage determined by the UGT1A1 status), 90 min IV infusion starting 30 min after the FA starts
* Homozygous 6/6 or 6/7: irinotecan will start at 150 mg/m², then will be increased according to clinical/biological tolerance by 10% steps, at each cycle, up to 180 mg/m² at max.
* Homozygous 7/7: irinotecan will start at 130 mg/m² in the first cycle then be increased up to a max of 150 mg/m², by 10% steps, according to tolerance.
5-FU: 5-FU (according to the DPD pharmacogenetic status), continuous IV infusion of 46 hours, starting at the end of FA infusion:
* If no DPD deficiency, 5-FU start at 1600 mg/m² and can be modulated according to clinical/biological tolerance after each course, i.e., 1800 mg/m² the 2nd course and 2000 mg/m² the 3rd one
* If partial DPD deficiency: 5-FU start at 1200 mg/m² and can be increased up to 1800, then 2000 if the clinical/biological tolerance are good at the 2nd and 3rd course.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=69 Participants
|
|
Age, Categorical
>=65 years
|
69 Participants
n=69 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=69 Participants
|
|
Region of Enrollment
France
|
69 participants
n=69 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation through Week 12This outcome is a composite assessment combining safety and early efficacy signals in the first 34 enrolled patients. Safety is measured by the occurrence of grade ≥3 toxicities (NCI-CTCAE v4.0). Early efficacy is assessed by the presence or absence of tumor response according to predefined stopping rules. Both components contribute jointly to the decision-making criteria for continuation of the study. This description corresponds specifically to the data reported in the Results section.
Outcome measures
| Measure |
FOLFIRINOX
n=69 Participants
FOLFIRINOX (D1-D15, for maximum 12 cycles) = Oxaliplatine + Folinic acid + Irinotecan + 5-FU
Oxaliplatine: Oxaliplatine : 85mg/m², 2-hours IV infusion (D1),
Folinic acid: Folinic acid (FA): 400 mg/m² , 2-hour IV infusion (D1),
Irinotecan: Irinotecan (at the dosage determined by the UGT1A1 status), 90 min IV infusion starting 30 min after the FA starts
* Homozygous 6/6 or 6/7: irinotecan will start at 150 mg/m², then will be increased according to clinical/biological tolerance by 10% steps, at each cycle, up to 180 mg/m² at max.
* Homozygous 7/7: irinotecan will start at 130 mg/m² in the first cycle then be increased up to a max of 150 mg/m², by 10% steps, according to tolerance.
5-FU: 5-FU (according to the DPD pharmacogenetic status), continuous IV infusion of 46 hours, starting at the end of FA infusion:
* If no DPD deficiency, 5-FU start at 1600 mg/m² and can be modulated according to clinical/biological tolerance after each course, i.e., 1800 mg/m² the 2nd course and 2000 mg/m² the 3rd one
* If partial DPD deficiency: 5-FU start at 1200 mg/m² and can be increased up to 1800, then 2000 if the clinical/biological tolerance are good at the 2nd and 3rd course.
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|---|---|
|
Composite Safety and Early Efficacy Assessment in the First 34 Patients
|
65.8 pourcentage of participants
Interval 53.2 to 75.8
|
Adverse Events
FOLFIRINOX
Serious events: 48 serious events
Other events: 69 other events
Deaths: 63 deaths
Serious adverse events
| Measure |
FOLFIRINOX
n=69 participants at risk
FOLFIRINOX (D1-D15, for maximum 12 cycles) = Oxaliplatine + Folinic acid + Irinotecan + 5-FU
Oxaliplatine: Oxaliplatine : 85mg/m², 2-hours IV infusion (D1),
Folinic acid: Folinic acid (FA): 400 mg/m² , 2-hour IV infusion (D1),
Irinotecan: Irinotecan (at the dosage determined by the UGT1A1 status), 90 min IV infusion starting 30 min after the FA starts
* Homozygous 6/6 or 6/7: irinotecan will start at 150 mg/m², then will be increased according to clinical/biological tolerance by 10% steps, at each cycle, up to 180 mg/m² at max.
* Homozygous 7/7: irinotecan will start at 130 mg/m² in the first cycle then be increased up to a max of 150 mg/m², by 10% steps, according to tolerance.
5-FU: 5-FU (according to the DPD pharmacogenetic status), continuous IV infusion of 46 hours, starting at the end of FA infusion:
* If no DPD deficiency, 5-FU start at 1600 mg/m² and can be modulated according to clinical/biological tolerance after each course, i.e., 1800 mg/m² the 2nd course and 2000 mg/m² the 3rd one
* If partial DPD deficiency: 5-FU start at 1200 mg/m² and can be increased up to 1800, then 2000 if the clinical/biological tolerance are good at the 2nd and 3rd course.
|
|---|---|
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Surgical and medical procedures
Biliray catheter insertion
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
gastrostomy
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
prosthesis implantation
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
transfusion
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Cardiac disorders
cardiac arrest
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiac failure
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
2/69 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
General disorders
General physical health deterioration
|
5.8%
4/69 • Number of events 4 • 2 years
|
|
General disorders
Asthenia
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
General disorders
Drug intolerance
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
General disorders
Malaise
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
2/69 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Abdomina pain
|
2.9%
2/69 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
1.4%
1/69 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Subileus
|
7.2%
5/69 • Number of events 5 • 2 years
|
|
Gastrointestinal disorders
vomiting
|
7.2%
5/69 • Number of events 5 • 2 years
|
|
Renal and urinary disorders
renal failure
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
urinary retention
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
cholangitis
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
hepatic cytolis
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
jaundice
|
2.9%
2/69 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
back pain
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
hyperglycemia
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
decreased appetite
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
dehydratation
|
2.9%
2/69 • Number of events 2 • 2 years
|
|
Infections and infestations
Device related infection
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Infections and infestations
sepsis
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Infections and infestations
septic shock
|
1.4%
1/69 • Number of events 1 • 2 years
|
|
Vascular disorders
superior vena cava syndrome
|
1.4%
1/69 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
FOLFIRINOX
n=69 participants at risk
FOLFIRINOX (D1-D15, for maximum 12 cycles) = Oxaliplatine + Folinic acid + Irinotecan + 5-FU
Oxaliplatine: Oxaliplatine : 85mg/m², 2-hours IV infusion (D1),
Folinic acid: Folinic acid (FA): 400 mg/m² , 2-hour IV infusion (D1),
Irinotecan: Irinotecan (at the dosage determined by the UGT1A1 status), 90 min IV infusion starting 30 min after the FA starts
* Homozygous 6/6 or 6/7: irinotecan will start at 150 mg/m², then will be increased according to clinical/biological tolerance by 10% steps, at each cycle, up to 180 mg/m² at max.
* Homozygous 7/7: irinotecan will start at 130 mg/m² in the first cycle then be increased up to a max of 150 mg/m², by 10% steps, according to tolerance.
5-FU: 5-FU (according to the DPD pharmacogenetic status), continuous IV infusion of 46 hours, starting at the end of FA infusion:
* If no DPD deficiency, 5-FU start at 1600 mg/m² and can be modulated according to clinical/biological tolerance after each course, i.e., 1800 mg/m² the 2nd course and 2000 mg/m² the 3rd one
* If partial DPD deficiency: 5-FU start at 1200 mg/m² and can be increased up to 1800, then 2000 if the clinical/biological tolerance are good at the 2nd and 3rd course.
|
|---|---|
|
Cardiac disorders
Hypertension
|
5.8%
4/69 • Number of events 9 • 2 years
|
|
Blood and lymphatic system disorders
aneamia
|
11.6%
8/69 • Number of events 9 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
21.7%
15/69 • Number of events 22 • 2 years
|
|
Nervous system disorders
neuropathy peripheral
|
11.6%
8/69 • Number of events 9 • 2 years
|
|
General disorders
Pain
|
10.1%
7/69 • Number of events 12 • 2 years
|
|
General disorders
anorexia
|
13.0%
9/69 • Number of events 12 • 2 years
|
|
General disorders
asthenia
|
29.0%
20/69 • Number of events 27 • 2 years
|
|
Gastrointestinal disorders
diarrhoea
|
18.8%
13/69 • Number of events 15 • 2 years
|
|
Gastrointestinal disorders
nausea
|
17.4%
12/69 • Number of events 20 • 2 years
|
|
Gastrointestinal disorders
vomitong
|
14.5%
10/69 • Number of events 13 • 2 years
|
|
Hepatobiliary disorders
bilirubin
|
5.8%
4/69 • Number of events 5 • 2 years
|
|
Hepatobiliary disorders
chlestasis
|
20.3%
14/69 • Number of events 43 • 2 years
|
|
Hepatobiliary disorders
cytolysis
|
8.7%
6/69 • Number of events 12 • 2 years
|
|
Hepatobiliary disorders
GT Gamma
|
55.1%
38/69 • Number of events 185 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place