Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer
NCT ID: NCT00506571
Last Updated: 2007-07-25
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
42 participants
INTERVENTIONAL
2007-07-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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S-1, irinotecan, oxaliplatin
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Principal Investigators
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Kyung Hae Jung, M.D.Ph.D.
Role: PRINCIPAL_INVESTIGATOR
not affiliated
Locations
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National Cancer Center Korea
Goyang-si, Gyeonggi-do, 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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NCCCTS-07-261
Identifier Type: -
Identifier Source: org_study_id