Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

S-1 and Irinotecan Combination Chemotherapy for Advanced Gastric Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Korean Cancer Study Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Korean Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00343668
First received: June 22, 2006
Last updated: May 25, 2010
Last verified: June 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • treatment-related toxicities [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.         
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.         
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.         
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.         
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

No publications provided

Responsible Party: Baek-Yeol Ryoo, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier: NCT00343668     History of Changes
Other Study ID Numbers: KCSG-ST05-02
Study First Received: June 22, 2006
Last Updated: May 25, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014