Efficacy and Tolerance Evaluation in FOLFIRINOX Dose Adjusted in Elderly Patients With a Metastatic Pancreatic Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

November 25, 2020

Study Completion Date

November 25, 2020

Conditions
Pancreatic Metastatic CancerToxicity
Interventions
DRUG

Oxaliplatine

Oxaliplatine : 85mg/m², 2-hours IV infusion (D1),

DRUG

Folinic acid

Folinic acid (FA): 400 mg/m² , 2-hour IV infusion (D1),

DRUG

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."

DRUG

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."

Trial Locations (6)

34298

ICM (Val d'Aurelle), Montpellier

35042

Centre Eugène marquis, Rennes

44805

ICO René Gauducheau, Saint-Herblain

49000

ICO Paul Papin, Angers

59020

Centre Oscar Lambret, Lille

85925

CH Vendée, La Roche-sur-Yon

All Listed Sponsors
lead

Institut Cancerologie de l'Ouest

OTHER

NCT02143219 - Efficacy and Tolerance Evaluation in FOLFIRINOX Dose Adjusted in Elderly Patients With a Metastatic Pancreatic Cancer | Biotech Hunter | Biotech Hunter