Metastatic colorectal cancer
Conditions
Interventions
S-1 +oxaliplatin (SOX) + cetuximab Cetuximab: loding dose 400 mg/m2, 250 mg/m2/week L-OHP: 75-130 mg/m2 tri-weekly S-1: 80 mg/m2 (80-120 mg/day)
Sponsors
Japan Clinical Cancer Research Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically proven colorectal cancer 2. Metastatic colorectal cancer with EGFR expressed 3. KRAS wild type in codon 12, 13 4. Presence of measurable lesion (RECIST Ver.1.) 5. No prior chemotherapy for unresectable primary tumor, metastases and lymph node metastasis. No primar therapy including surgery for recurrent that should be the first relapse after surgery for primary or metastases tumors 6. ECOG Performance Status (PS) 0-1 7. Age over 20 years (Age between 20 to 79 years in Phase I) 8. Life expectancy of more than 3 months 9. Oral food intake possible 10. Patients have enough organ function for study treatment 11. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval 2. Symptomatic brain metastases 3. Severe infectious disease 4. Interstitial lung disease or pulmonary fibrosis 5. Comorbidity or history of heart failure 6. Sensory alteration or paresthesia interfering with function 7. Large quantity of pleural, abdominal or cardiac effusion 8. Severe comorbidity (renal failure, liver failure, hypertension, etc) 9. Prior radiotherapy for primary and metastases tumors 10. Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test 11. History of severe allergy 12. History of allergy for L-OHP and other platinating agent 13. Prior treatment of cetuximab or L-OHP or TS-1 14. Administration of flucytosine 15. Any other cases who are regarded as inadequate for study enrollment by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Maximum Tolerated Dose, Recommended Dose Phase II: Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: Safety, Response Rate Phase II: Overall Survival, Progression Free Survival, Safety | — |
Countries
Japan
Contacts
Public ContactWataru Ichikawa
National Defense Medical College Hospital Department of Clinical Oncology
Outcome results
None listed