NCT01693445

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 19, 2016

Status Verified

September 1, 2012

Enrollment Period

1.7 years

First QC Date

September 20, 2012

Last Update Submit

February 18, 2016

Conditions

Gastrointestinal Neoplasms

Keywords

Gastrointestinal neoplasmsOxaliplatinIrinotecanS-1

Outcome Measures

Primary Outcomes (1)

  • maximum tolerated dose

    6 months

Secondary Outcomes (5)

  • toxicity profiles

    6 months

  • overall response rate

    6 months

  • progression free survival

    6 months

  • overall survival

    6 months

  • disease control rate

    6 months

Study Arms (1)

OIS (Oxaliplatin, Irinotecan, S-1)

EXPERIMENTAL

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.

Drug: OIS (Oxaliplatin, Irinotecan, S-1)

Interventions

OIS (Oxaliplatin, Irinotecan, S-1)DRUG

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.

Also known as: Kabioxaliplatin, Campto, TS-1
OIS (Oxaliplatin, Irinotecan, S-1)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven recurrent or metastatic adenocarcinoma of the gastrointestinal tract
  • Minimum age of 18 years
  • ECOG Performance status 0-2
  • Life expectancy \>3 months
  • Presence of measurable or evaluable disease by RECIST
  • Prior adjuvant chemotherapy without S-1, oxaliplatin and irinotecan is allowed if more than 4 weeks elapsed since completion of chemotherapy.
  • More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions should be outside the radiation field)
  • Adequate organ functions
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

You may not qualify if:

  • Patients treated previously with S-1, oxaliplatin, or irinotecan as adjuvant chemotherapy.
  • Patients with CNS metastases or carcinomatous leptomeningitis or neurologic disease.
  • Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
  • Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Medical Center

Anyang, South Korea

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

OxaliplatinIrinotecanS 1 (combination)titanium silicide

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Dae Young Zang, MD, PhD

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 26, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2014

Study Completion

August 1, 2014

Last Updated

February 19, 2016

Record last verified: 2012-09

Locations

KR(1)