Phase I/II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) in Patients With Untreated Metastatic Colorectal Cancer
- Written informed consent.
- Adequate oral intake.
- Histologically proved adenocarcinoma (colorectal cancer).
- Unresectable, recurrent and advanced colorectal cancer.
- At least 4 weeks since prior major surgery
- Age: 20 - 74 at enrollment.
- Performance Status (Eastern Cooperative Oncology Group [ECOG] scale): 0 - 2.
- No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to
advanced disease. Patients who received adjuvant chemotherapy more than 180 days
before enrollment can be allowed but those who received S-1 or Oxaliplatin containing
treatment shall be excluded.
- Proved presence of measurable lesions within 30 days before enrollment.
- Patients with the following function of bone marrow, liver and kidney based on the
laboratory values measured within 15 days before enrollment.
- Hemoglobin >_ 9.0g/dL
- WBC: LLN - 12,000/mm3
- Absolute granulocyte count >_ 1,500/mm3
- Platelets >_ 100,000/mm3
- Total Bilirubin <_ 1.5mg/dL
- AST(GOT) and ALT(GPT) <_ 100U/L
- ALP <_ 600U/L
- Creatinine <_ 1.0mg/dl
- Expected to survive more than 90 days after enrollment.
- Patients who not received S-1 and Oxaliplatin as neoadjuvant or adjuvant
chemotherapies before enrollment.
- Contraindication to S-1, and serious hypersensitivity to oral Leucovorin.
- No other concurrent investigational therapy.
- Patients did who not received blood transfusion and hematogenesis stimulating agents
(ex. Granulocyte-Colony Stimulating Factor).
- Serious drug hypersensitivity.
- Prior history of peripheral neuropathy.
- Marked infection or inflammation (ex. patients with a fever of 38.0 degrees or
- Poorly-controlled diabetes, hypertension or hypercalcemia.
- Severe (inpatient care is needed) arrhythmia, heart disease or its history.
- Severe (inpatient care is needed) lung disease (ex. interstitial pneumonia or
- Psychiatric disorder requiring to receive treatment with antipsychotic drug.
- Fresh bleeding from the gastrointestinal tract.
- Requiring to drainage massive ascites, pleural effusion retention or pericardial
- Extensive bone metastasis.
- Clinically suspicious brain metastasis or brain metastasis.
- Diarrhea (watery diarrhea).
- Simultaneously active double cancer.
- Pregnancy or nursing female patients and possibility (intent) to bear baby. Male
patients with intent to impregnate.
- Other patients evaluated to be inadequate to participate in the study by (sub)