Phase I/II Study of SOL for Untreated Metastatic Colorectal Cancer

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 higher).
• 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 pulmonary fibrosis).
• 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 fluid.
• 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) investigators.