S-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

February 28, 2014

Study Completion Date

August 31, 2014

Conditions
Gastrointestinal Neoplasms
Interventions
DRUG

OIS (Oxaliplatin, Irinotecan, S-1)

"Dose level 1 treatment will be delivered as a 2-week cycle as bellows;~1. Oxaliplatin 85 mg/m²IV on day 1~2. Irinotecan 120 mg/m² IV on day 1~3. S-1 60 mg/m2/day PO on day 1-7~Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level."

Trial Locations (1)

Unknown

Hallym University Medical Center, Anyang

All Listed Sponsors
collaborator

Jeil Pharmaceutical Co., Ltd.

INDUSTRY

collaborator

HK inno.N Corporation

INDUSTRY

collaborator

Pfizer

INDUSTRY

collaborator

Handok Inc.

INDUSTRY

lead

Hallym University Medical Center

OTHER