Colorecal Neoplasms, Secondary
Conditions
Keywords
colorectal neoplasms, secondary, Combination chemotherapy, S-1, irinotecan, oxaliplatin
Brief summary
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.
Interventions
Sponsors
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal overall response rate | During chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism | — |
Countries
South Korea
Contacts
Primary ContactKyung Hae Jung, M.D.Ph.D
Backup ContactHwa Jung Kim
Outcome results
None listed