Secondary Clinical Trial
— TIROX2Official title:
Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer
Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed every 2 cycles of chemotherapy.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | June 2010 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed unresectable or metastatic colorectal cancer, not amenable to surgery or radiation treatment for curative intent - 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 systemic chemotherapy for metastatic disease - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Cancer Center Korea | Goyang | Gyeonggi |
Lead Sponsor | Collaborator |
---|---|
National Cancer Center, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal overall response rate | During chemotherapy | ||
Secondary | Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism |
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