A Trial Assessing Several Schedules of Oral S-1 in Combination With a Fixed Dose of Oxaliplatin and Irinotecan

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

June 30, 2018

Study Completion Date

September 30, 2018

Conditions
Digestive Cancer
Interventions
DRUG

S-1

"S-1: Administered orally twice daily from day 1 for 7 consecutive days followed by a 7-day recovery period in a 14-day cycle.~The starting dose of S-1 will be two levels below the recommended dose defined in SIRI (20 mg/m² BID minimum) with a cohort dose escalation by 5 mg/m² increments (5 dose levels)."

DRUG

Irinotecan

Irinotecan : fixed dose of 180 mg/m² IV over 90 minutes on d1 of every cycle

DRUG

Oxaliplatin

Oxaliplatin : fixed dose of 85 mg/m² over 120 minutes on d1 of every cycle

OTHER

G-csf

G-csf : d8 to d13 systematically

Trial Locations (1)

34298

Institut du Cancer de Montpellier - Val d'Aurelle, Montpellier

All Listed Sponsors
lead

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

NCT02387138 - A Trial Assessing Several Schedules of Oral S-1 in Combination With a Fixed Dose of Oxaliplatin and Irinotecan | Biotech Hunter | Biotech Hunter