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

Conditions

• Digestive Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• S-1 — DRUG
  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).
• Irinotecan — DRUG
  Irinotecan : fixed dose of 180 mg/m² IV over 90 minutes on d1 of every cycle
• Oxaliplatin — DRUG
  Oxaliplatin : fixed dose of 85 mg/m² over 120 minutes on d1 of every cycle
• G-csf — OTHER
  G-csf : d8 to d13 systematically

Study Details

This study is to determine the Maximal Tolerated Dose (MTD), the Dose Limitant Toxicities (DLTs) and the safety profile of S-1 combined with fixed doses of Irinotecan (SIRI schedule) and fixed doses of Irinotecan and Oxaliplatin (SIRINOX schedule).

Key Dates

Start date

Apr 30, 2014

Status verified

Aug 2017

Primary completion

Jun 30, 2018

Completion

Sep 30, 2018

Study Design

Enrollment

24 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: SIRINOX
  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). Irinotecan : fixed dose of 180 mg/m² IV over 90 minutes on d1 of every cycle Oxaliplatin : fixed dose of 85 mg/m² over 120 minutes on d1 of every cycle G-csf : d8 to d13 systematically

Primary Outcome Measure

Dose limiting toxicities [ Time Frame: up to 5 years ]