Status:
COMPLETED
Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM)
Lead Sponsor:
Technische Universität Dresden
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
General Objectives: * To test the feasibility of neoadjuvant treatment with cetuximab/chemotherapy followed by liver resection * To determine the optimal combination (cetuximab/FOLFOX versus cetuxima...
Detailed Description
Patients with liver metastasis will be screened for this study. Eligible patients will complete the pretreatment evaluation including an abdominal CT scan that will be presented to the local surgeon a...
Eligibility Criteria
Inclusion
- Patients with non-resectable, histologically confirmed, synchronous or metachronous colorectal liver metastases. Patients with non-resectable metastases are defined as; patients with five or more liver metastases; and/or patients with liver metastases that are technically non-resectable (local surgeon in cooperation with local radiologist will define non-resectability on the basis of remaining functional liver tissue, infiltration of all liver veins, infiltration of both liver arteries, both portal branches or both bile ducts).
- Patients with simultaneous liver metastases are eligible, if the primary tumor has been resected at least 1 month prior to chemotherapy.
- Karnofsky Performance Status ≥ 80
- Informed consent
- Adequate bone marrow function, liver and renal function (neutrophils \> 1.5 x 10\^9/l; thrombocytes \> 100 x 10\^9/l; hemoglobin \> 8.0 g/l; bilirubin ≤ 1.5 x upper limit of normal \[ULN\] and not increasing more than 25% within the last 4 weeks; ALAT and ASAT \< 5 x UNL; serum creatinine ≤ 1.5 x UNL)
- Age ≥ 18 years
Exclusion
- Any evidence of extrahepatic metastases, lymph node metastases and primary tumor recurrence
- Prior chemotherapy (except adjuvant chemotherapy with an interval of ≥ 6 months)
- Previous exposure to EGFR (epidermal growth factor receptor)-targeting therapy
- Radiotherapy or major abdominal or thoracic surgery (excluding diagnostic biopsy or port implantation) ≤ 4 weeks before study entry
- Concurrent systemic immune therapy, chemotherapy, or hormone therapy
- Investigational agents or participation in clinical trials within 30 days before start of the treatment in study
- Clinically relevant coronary disease or myocardial infarction within 12 months before study entry
- Peripheral neuropathy \> CTC grade I
- Inflammatory bowel disease
- Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
- History of severe psychiatric illness
- Drug or alcohol abuse
- Breast feeding or pregnant women, no effective contraception if risk of conception exists (male and female patients)
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00153998
Start Date
November 1 2004
Last Update
February 27 2009
Active Locations (21)
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1
Medizinische Universitaet Wien, Universitaetsklinik für Chirurgie
Vienna, Austria, A-1090
2
Kreiskrankenhaus Aschersleben
Aschersleben, Germany, 06449
3
Charite-Campus Benjamin Franklin, Innere Medizin
Berlin, Germany, 12200
4
Charite-Campus, Virchow-Klinikum, Innere Medizin
Berlin, Germany, 13353