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S-1 and Irinotecan Combination Chemotherapy for Advanced Gastric Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Korean Cancer Study Group.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00343668
First Posted: June 23, 2006
Last Update Posted: May 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Korean Cancer Study Group
  Purpose
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.

Condition Intervention Phase
Gastric Cancer Drug: S-1, irinotecan Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of S-1 and Irinotecan Combination Chemotherapy in Patients With Advanced Gastric Cancer as a First-Line Therapy

Resource links provided by NLM:


Further study details as provided by Korean Cancer Study Group:

Primary Outcome Measures:
  • response rate [ Time Frame: best response ]

Secondary Outcome Measures:
  • treatment-related toxicities [ Time Frame: during treatment ]

Estimated Enrollment: 44
Study Start Date: September 2005
Estimated Study Completion Date: July 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: S-1, irinotecan
    S-1, 40 mg/m2 PO twice daily, days 1-14 irinotecan, 150 mg/m2 IV, day 1
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343668


Contacts
Contact: Baek-Yeol Ryoo, M.D., Ph.D. +82-2-970-1208 ryooby@kcch.re.kr
Contact: Hye Jin Kang, M.D. +82-2-970-1289 hyejin@kcch.re.kr

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun-gun, Jeolanam-do, Korea, Republic of, 519-809
Contact: Sang Hee Cho, M.D., Ph.D.    +82-61-379-7633    sh115@chollian.net   
Sub-Investigator: Sang Hee Cho, M.D., Ph.D.         
Chonbuk National University Hospital Not yet recruiting
Jeonju, Jeonbuk, Korea, Republic of, 561-712
Contact: Eun Kee Song, M.D.    +82-63-250-1245    eksong@chonbuk.ac.kr   
Principal Investigator: Eun Kee Song, M.D.         
Inha University hospital Not yet recruiting
Inchon, Korea, Republic of
Contact: Moon Hee Lee, M.D., Ph.D.    +82-32-890-2583    moonhlmd@inha.ac.kr   
Principal Investigator: Moon Hee Lee, M.D., Ph.D.         
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine Not yet recruiting
Seoul, Korea, Republic of, 110-746
Contact: Seung Sei Lee, M.D., Ph.D.    +82-2-2001-2084    llssss.lee@samsung.com   
Principal Investigator: Seung Sei Lee, M.D., Ph.D.         
Sub-Investigator: Suk Joong Oh, M.D., Ph.D.         
Sub-Investigator: Kwon Choi, M.D.         
Yonsei Cancer Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hyun Cheol Chung, M.D., Ph.D.    +82-2-2228-8132    unchung8@yumc.yonsei.ac.kr   
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 Veterans Hospital Not yet recruiting
Seoul, Korea, Republic of, 134-791
Contact: Bong-Seog Kim, M.D., Ph.D.    +82-2-2225-1319    seog@e-bohun.or.kr   
Principal Investigator: Bong-Seog Kim, M.D., Ph.D.         
Korea Institute of radiological and Medical Sciences Recruiting
Seoul, Korea, Republic of, 139-706
Contact: Baek-Yeol Ryoo, M.D., Ph.D.    +82-2-970-1208    ryooby@kcch.re.kr   
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.         
Sponsors and Collaborators
Korean Cancer Study Group
Investigators
Principal Investigator: Baek-Yeol Ryoo, M.D., Ph.D. Korea Institute of Radiological and Medical Sciences
  More Information

Responsible Party: Baek-Yeol Ryoo, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier: NCT00343668     History of Changes
Other Study ID Numbers: KCSG-ST05-02
First Submitted: June 22, 2006
First Posted: June 23, 2006
Last Update Posted: May 26, 2010
Last Verified: June 2006

Keywords provided by Korean Cancer Study Group:
advanced gastric cancer
First-line therapy
S-1
irinotecan

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action