Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer (TIROX2)

July 23, 2007 updated by: National Cancer Center, Korea

Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer

Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed every 2 cycles of chemotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kyung Hae Jung, M.D.Ph.D
  • Phone Number: +82-31-920-1611
  • Email: khjung@ncc.re.kr

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 410-769
        • Recruiting
        • National Cancer Center Korea
        • Contact:
          • Kyung Hae Jung, M.D.Ph.D
          • Phone Number: +82-31-920-1611
          • Email: khjung@ncc.re.kr
        • Contact:
        • Sub-Investigator:
          • Yong Sang Hong, M.D.
        • Sub-Investigator:
          • Sun Young Kim, M.D.
        • Sub-Investigator:
          • Hye Suk Han, M.D.
        • Sub-Investigator:
          • Seung-Yong Jeong, M.D.Ph.D
        • Sub-Investigator:
          • Hyo Seong Choi, M.D.
        • Sub-Investigator:
          • Seok-Byung Lim, M.D.
        • Sub-Investigator:
          • Hee Jin Chang, M.D.Ph.D.
        • Sub-Investigator:
          • Jun Yong Jeong, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed unresectable or metastatic colorectal cancer, not amenable to surgery or radiation treatment for curative intent
  • At least one unidimensional measurable lesion
  • ECOG performance status 0-2.
  • No prior chemotherapy in metastatic settings, but adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment
  • Adequate major organ functions
  • Give written informed consent

Exclusion Criteria:

  • Prior systemic chemotherapy for metastatic disease
  • Prior treatment with oxaliplatin or irinotecan
  • Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
  • Prior surgical treatment of stage IV disease is permitted
  • CNS metastases
  • Prior history of peripheral neuropathy ≥ NCI CTC grade 1
  • Uncontrolled or severe cardiovascular disease
  • Serious concurrent infection or nonmalignant illness
  • Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
  • Organ allografts requiring immunosuppressive therapy
  • Psychiatric disorder or uncontrolled seizure that would preclude compliance
  • Pregnant, nursing women or patients with reproductive potential without contraception
  • Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Known hypersensitivity to platinum compounds or any of the components of the study medications
  • Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery
  • Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal overall response rate
Time Frame: During chemotherapy
During chemotherapy

Secondary Outcome Measures

Outcome Measure
Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Kyung Hae Jung, M.D.Ph.D., Not Affiliated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion

December 7, 2022

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

July 23, 2007

First Submitted That Met QC Criteria

July 23, 2007

First Posted (Estimate)

July 25, 2007

Study Record Updates

Last Update Posted (Estimate)

July 25, 2007

Last Update Submitted That Met QC Criteria

July 23, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-07-261

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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