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