A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675)

Inclusion Criteria: 1. Patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis; 2. At least one measurable lesion either by computer tomography (CT) scan or magnetic resonance imaging (MRI); 3. Aged 20 years old or above; 4. Eastern Cooperative Oncology Group (ECOG) performance status \< 2; 5. Adequate bone marrow reserve (hemoglobin \> 9 g/dl, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L); 6. Adequate renal and hepatic functions: total bilirubin \< 1.25 x upper normal limit, creatinine \< 1.25 x upper normal limit, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5 x upper normal limit; 7. Patients willing to participate in the trial and giving written informed consent. Exclusion Criteria: 1. Pregnant or lactating patients; 2. Patients (male or female) with reproductive potential not using adequate contraceptive measures; 3. Patients with evidence of central nervous system metastasis; 4. Subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents 5. Current history of chronic diarrhea; 6. Other serious illness or medical conditions (e.g.: history of angina, myocardial infarction); 7. History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; 8. Concurrent treatment with any other anticancer therapy; 9. Patients with congestive heart failure (New York Heart Association Functional Classification III or IV), epilepsy, or other significant medical conditions as judged by the investigator; 10. Patients treated with another investigational drug within 4 weeks of entry into this study.