Phase l and Phase ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
- Conditions
- Metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000007022
- Lead Sponsor
- Japan Clinical Cancer Research Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 56
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Maximum Tolerated Dose, Recommended Dose Phase II: Response Rate
- Secondary Outcome Measures
Name Time Method Phase I: Safety, Response Rate Phase II: Overall Survival, Progression Free Survival, Safety