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

NCT01693445 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-02-19

No results posted yet for this study

Summary

This study will attempt to determine the feasibility of combination of Oxaliplatin, Irinotecan, and S-1, the maximum tolerated dose and the recommended doses of the agents used, and to preliminarily evaluate the antitumor activity in untreated patients with advanced gastrointestinal cancer.

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.

Sponsors & Collaborators

  • Jeil Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • HK inno.N Corporation

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Handok Inc.

    collaborator INDUSTRY

  • Hallym University Medical Center

    lead OTHER

Principal Investigators

  • Dae Young Zang, MD, PhD · Hallym University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-02-28
Completion
2014-08-31

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01693445 on ClinicalTrials.gov