Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 cetuximab/FOLFIRI) for further trials in preoperative chemotherapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Camptothecin; Cetuximab; Fluorouracil; Folic Acid; Irinotecan; Leucovorin; Levoleucovorin; Liver Extracts; Oxaliplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)