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Role of Erbitux plus a combination of CPT-11/5-fluorouracil/leucovorin/oxaliplatin as neoadjuvant chemotherapy in patients with colorectal liver metastases - Cetuximab plus triplet

Role of Erbitux plus a combination of CPT-11/5-fluorouracil/leucovorin/oxaliplatin as neoadjuvant chemotherapy in patients with colorectal liver metastases - Cetuximab plus triplet

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-006205-28-IT
Enrollment
Unknown
Registered
2007-09-14
Start date
2006-04-15
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver metastases from colorectal cancer MedDRA version: 6.1 Level: PT Classification code 10027457

Interventions

Trade Name: ERBITUX*INFUS 1FL 50ML 2MG/ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: CETUXIMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Sponsors

ISTITUTI FISIOTERAPICI OSPITALIERI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed colorectal adenocarcinoma. 2. Liver metastases from colorectal cancer. Patients will be considered non resectable according to the following criteria: - Size - Multinodular - Ilar location - Extraepatic disease - Patients with >3 metastases who receive chemotherapy in order to stabilize liver disease before surgery - Patients who present with huge resectable liver metastases at the time of resection of the primary tumor and need extended liver surgery 3. Presence of resectable lesions in other sites, as isolated lung or abdominal lesions. 4. Evaluation of EGFR in metastases by immunohistochemistry. Patients EGFR negative can be enrolled. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Brain and bone metastasis. 2. Radiotherapy within 4 weeks prior to study entry. 3. Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy. 4. Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months. 5. Acute or subacute intestinal occlusion or history of the inflammatory bowel disease.

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the rate of patients submitted to surgery for liver metastases after a triplet induction chemotherapy (CPT-11, 5-fluorouracil-leucovorin, oxaliplatin) plus Erbitux in patients with liver metastases from colorectal cancer;Secondary Objective: a. Rate of Pathological complete remission; b. Tolerability of the combination; c. Time to disease progression; d. Overall survival;Primary end point(s): Resection rate of liver metastases—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026