S-1 and Irinotecan Combination Chemotherapy for Advanced Gastric Cancer

May 25, 2010 updated by: Korean Cancer Study Group

A Phase II Study of S-1 and Irinotecan Combination Chemotherapy in Patients With Advanced Gastric Cancer as a First-Line Therapy

The primary goal of this phase II trial is to evaluate the response rate of combination chemotherapy with S-1 and Irinotecan in patients with advanced gastric cancer as a first-line therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

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: Baek-Yeol Ryoo, M.D., Ph.D.
  • Phone Number: +82-2-970-1208
  • Email: ryooby@kcch.re.kr

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Inchon, Korea, Republic of
        • Not yet recruiting
        • Inha University Hospital
        • Contact:
        • Principal Investigator:
          • Moon Hee Lee, M.D., Ph.D.
      • Seoul, Korea, Republic of, 110-746
        • Not yet recruiting
        • Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
        • Contact:
        • Principal Investigator:
          • Seung Sei Lee, M.D., Ph.D.
        • Sub-Investigator:
          • Suk Joong Oh, M.D., Ph.D.
        • Sub-Investigator:
          • Kwon Choi, M.D.
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Yonsei Cancer Center
        • Contact:
        • Principal Investigator:
          • Hyun Cheol Chung, M.D., Ph.D.
        • Sub-Investigator:
          • Sun Young Rha, M.D., Ph.D.
        • Sub-Investigator:
          • Hei-Cheul Jeung, M.D., Ph.D.
      • Seoul, Korea, Republic of, 134-791
        • Not yet recruiting
        • Seoul Veterans Hospital
        • Contact:
        • Principal Investigator:
          • Bong-Seog Kim, M.D., Ph.D.
      • Seoul, Korea, Republic of, 139-706
        • Recruiting
        • Korea Institute of Radiological and Medical Sciences
        • Contact:
        • Principal Investigator:
          • Baek-Yeol Ryoo, M.D., Ph.D.
        • Sub-Investigator:
          • Sung Hyun Yang, M.D., Ph.D.
        • Sub-Investigator:
          • Hye Jin Kang, M.D.
        • Sub-Investigator:
          • Im Il Nah, M.D.
    • Jeolanam-do
      • Hwasun-gun, Jeolanam-do, Korea, Republic of, 519-809
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
        • Sub-Investigator:
          • Sang Hee Cho, M.D., Ph.D.
    • Jeonbuk
      • Jeonju, Jeonbuk, Korea, Republic of, 561-712
        • Not yet recruiting
        • Chonbuk National University Hospital
        • Contact:
        • Principal Investigator:
          • Eun Kee Song, 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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically proven unresectable adenocarcinoma of stomach
  • With uni-dimensionally measurable disease (at least longest diameter 2 cm on conventional CT scan, x-ray or physical examination, or 1cm on spiral CT scan)
  • Age 18 to 70 years old
  • Estimated life expectancy of more than 3 months
  • ECOG performance status of 2 or lower
  • Adequate bone marrow function(absolute neutrophil count [ANC] ≥1,500/µL, hemoglobin ≥9.0 g/dL,and platelets ≥100,000/µL)
  • Adequate kidney function (serum creatinine < 1.5 mg/dL)
  • Adequate liver function (serum total bilirubin < 2 times the upper normal limit (UNL); serum transaminases levels <3 times [<5 times for patients with liver metastasis] UNL)
  • No prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed. (but, prior adjuvant chemotherapy with capecitabine or S-1 or camptothecin analogues was excluded)
  • No prior radiation therapy for at least 4 weeks before enrollment in the study

Exclusion Criteria:

  • Other tumor type than adenocarcinoma
  • Central nervous system (CNS) metastases or prior radiation for CNS metastases
  • Gastric outlet obstruction or intestinal obstruction
  • Evidence of gastrointestinal bleeding
  • The patient has bony lesions as the sole evaluable disease.
  • Past or concurrent history of neoplasm other than stomach cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception

  • Other serious illness or medical conditions

    • Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
    • History of significant neurologic or psychiatric disorders including dementia or seizures
    • Active uncontrolled infection
    • Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
  • Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

  • concomitant drug medication; The following drugs cause drug interaction with S-1.

    i. Warfarin, phenprocoumon: increase bleeding tendency ii. Increase blood concentration of phenytoin iii. sorivudine: inhibit DPD -> increase toxicity according to fluoropyrimidine iv. allopurinol : decrease activity of S-1

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: best response
best response

Secondary Outcome Measures

Outcome Measure
Time Frame
treatment-related toxicities
Time Frame: during treatment
during treatment

Collaborators and Investigators

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

Sponsor

Korean Cancer Study Group

Investigators

  • Principal Investigator: Baek-Yeol Ryoo, M.D., Ph.D., Korea Institute of Radiological and Medical Sciences

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

September 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Anticipated)

July 1, 2008

Study Registration Dates

First Submitted

June 22, 2006

First Submitted That Met QC Criteria

June 22, 2006

First Posted (Estimate)

June 23, 2006

Study Record Updates

Last Update Posted (Estimate)

May 26, 2010

Last Update Submitted That Met QC Criteria

May 25, 2010

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCSG-ST05-02

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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