Status:
COMPLETED
Neoadjuvant FOLFOX6 + Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
Lead Sponsor:
Samsung Medical Center
Conditions:
Colorectal Cancer
Unresectable Liver Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
An innovative therapeutic strategy to increase the complete resection rate is of utmost importance in order to enhance survival in colorectal cancer patients with unresectable liver-only metastasis. T...
Detailed Description
We will include the patients with unresectable liver-only metastatic disease independent of EGFR status. The results of this study will show the resection rate with neoadjuvant treatment in patients w...
Eligibility Criteria
Inclusion
- Histologically proven colorectal cancer with metastatic lesion(s) in the liver that is (are) unresectable
- Age ≥ 18
- ECOG performance 0 - 1
- Adequate organ function ((hepatic transaminases ≤ 5x upper limit of normal, bilirubin \< 2.0 x upper limit of normal, and creatinine ≤ 1.5x upper limit of normal, platelet \> 100,000/ul, absolute neutrophil count ≥ 1,500/ul)
- At least one measurable lesion by RECIST criteria
- Written informed consent
Exclusion
- Resectable liver metastasis
- Extrahepatic metastases, regardless of their resectability
- Chronic active hepatitis or cirrhosis
- Prior therapy for metastatic disease
- Pregnant or lactating women
- Uncontrolled medical illnesses including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months
- Previous adjuvant FOLFOX chemotherapy
- Prior adjuvant chemotherapy, if administered within 6 months before study entry
- Known hypersensitivity reaction to any of the components of study treatment
- Prior agents directed against EGFR
- Prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapy
- Known alcohol or drug abuse
- Participation in another clinical study within the 30 days before registration
- Peripheral neuropathy \> grade 1
- Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin of pre-invasive carcinoma of the cervix.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00743678
Start Date
June 1 2008
End Date
June 1 2012
Last Update
June 14 2013
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710