Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer

Conditions
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Colorecal Neoplasms, Secondary

Intervention / Treatment
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* Drug: S-1, irinotecan, oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: S-1, irinotecan, oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal overall response rate |  | During chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal neoplasms, secondary, Combination chemotherapy, S-1, irinotecan, oxaliplatin