S-1 and Irinotecan Combination Chemotherapy for Advanced Gastric Cancer
NCT ID: NCT00343668
Last Updated: 2010-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
44 participants
INTERVENTIONAL
2005-09-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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S-1, irinotecan
S-1, 40 mg/m2 PO twice daily, days 1-14 irinotecan, 150 mg/m2 IV, day 1
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Korean Cancer Study Group
OTHER
Responsible Party
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Korea Cancer Center Hospital
Principal Investigators
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Baek-Yeol Ryoo, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Korea Institute of Radiological and Medical Sciences
Locations
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Chonnam National University Hwasun Hospital
Hwasun-gun, Jeolanam-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Inha University hospital
Inchon, , South Korea
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, , South Korea
Yonsei Cancer Center
Seoul, , South Korea
Seoul Veterans Hospital
Seoul, , South Korea
Korea Institute of radiological and Medical Sciences
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KCSG-ST05-02
Identifier Type: -
Identifier Source: org_study_id
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